[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511990":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":528,"collaborators":530,"id":536,"slug":537,"hasResults":538,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":26,"eligibilityCriteria":542,"healthyVolunteers":538,"sex":543,"minAge":544,"maxAge":26,"enrollmentInfo":545,"targetDuration":26,"studyType":548,"phases":549,"briefSummary":551,"conditions":552,"keywords":554,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":576},{"fullName":5,"class":6},"M.A. Med Alliance S.A.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SELUTION SLR 014 PTCA DEB","EXPERIMENTAL","SELUTION Sustained Limus Release (SLR) 014 Percutaneous Transluminal Coronary Angioplasty (PTCA) Drug Eluting Balloon (DEB)\n\nThe SELUTION SLR 014 PTCA DEB is a minimally invasive, single use and sterile Sirolimus coated PTCA balloon catheter.\n\nThe SELUTION SLR 014 PTCA DEB is available with balloon diameters from 2.0 to 3.0 mm and lengths of 15 to 40 mm for the purpose of the De Novo IDE trial",[13],"Device: PCI with SELUTION SLR DCB",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Treatment","ACTIVE_COMPARATOR","any FDA approved \"limus-based\" Drug Eluting Stent, as per standard institutional practice",[19],"Device: PCI with FDA approved \"-limus\" DES",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","PCI with SELUTION SLR DCB","After target lesion pre-dilatation and preparation , a SELUTION SLR 014 PTCA DEB study device should be selected with nominal diameter equal to the RVD of the target lesion (1:1 ratio) and length that allows approximately 2.00 mm longer than the proximal and distal edges of the target lesion (defined as the proximal and distal extent of predilation). If IVUS is performed to assess RVD, and DEB upsizing is deemed clinically necessary for optimal results, a maximum nominal DEB diameter of 3.0 mm is permitted. The SELUTION SLR 014 PTCA DEB should then be delivered, positioned in and deployed per instructions per use. The balloon should be inflated for 60 seconds provided that the patient can tolerate this duration. The minimum inflation time is 30 seconds.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"PCI with FDA approved \"-limus\" DES","For subjects randomized to the control group (DES), the treating physician will choose an FDA cleared DES and follow lesion preparation and stent deployment according to the Instructions per use (IFU) and institutional practices.\n\nThe DES should be sized per IFU with respect to the vessel RVD. The use of IVUS or OCT is encouraged to guide optimal stent placement and assess final results. After DES deployment, additional balloon inflations should be performed as needed to obtain \\\u003C 30% residual diameter stenosis and resolve proximal or distal edge dissections greater than or equal to NHLBI grade B.",[15],[32],{"name":33,"affiliation":34,"role":35},"Ron Waksman, MD","Medstar Health Research Institute","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Rebecca Apruzzese","CONTACT","2016001527","rebecca.apruzzese@cordis.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Susanne Meis","+491718918919","susanne.meis@cordis.com",[47,65,77,88,99,110,122,133,145,156,167,178,189,200,212,220,228,239,251,262,274,286,296,308,315,323,334,346,354,366,377,389,401,413,424,436,448,460,471,482,493,504,516],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"St. Bernards","RECRUITING","Jonesboro","Arkansas","72401","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-90.70428,35.8423,{"lat":59,"lon":58},[62],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},"MedAlliance Clinical Research","selutiondenovoide@medalliance.com",{"facility":66,"status":49,"city":67,"state":68,"zip":69,"country":53,"countryCode":54,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"CISD Sharp Chula Vista","Chula Vista","California","91911",{"type":56,"coordinates":71},[72,73],-117.0842,32.64005,{"lat":73,"lon":72},[76],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":78,"status":49,"city":79,"state":68,"zip":80,"country":53,"countryCode":54,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Cedars Sinai","Los Angeles","90048",{"type":56,"coordinates":82},[83,84],-118.24368,34.05223,{"lat":84,"lon":83},[87],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":89,"status":49,"city":90,"state":68,"zip":91,"country":53,"countryCode":54,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"HCA Los Robles","Thousand Oaks","91360",{"type":56,"coordinates":93},[94,95],-118.83759,34.17056,{"lat":95,"lon":94},[98],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":100,"status":49,"city":101,"state":68,"zip":102,"country":53,"countryCode":54,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Harbor UCLA","Torrance","90502",{"type":56,"coordinates":104},[105,106],-118.34063,33.83585,{"lat":106,"lon":105},[109],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":111,"status":49,"city":112,"state":113,"zip":114,"country":53,"countryCode":54,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Colorado Heart and Vascular","Golden","Colorado","80401",{"type":56,"coordinates":116},[117,118],-105.2211,39.75554,{"lat":118,"lon":117},[121],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":123,"status":49,"city":124,"state":113,"zip":125,"country":53,"countryCode":54,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"ClinRe","Thornton","80023",{"type":56,"coordinates":127},[128,129],-104.97192,39.86804,{"lat":129,"lon":128},[132],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":134,"status":49,"city":135,"state":136,"zip":137,"country":53,"countryCode":54,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"MedStar Washington Hospital Center","Washington D.C.","District of Columbia","20010",{"type":56,"coordinates":139},[140,141],-77.03637,38.89511,{"lat":141,"lon":140},[144],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":146,"status":147,"city":148,"state":149,"zip":150,"country":53,"countryCode":54,"cosmosGeoPoint":151,"geoPoint":155,"contacts":26},"HCA Florida JFK","WITHDRAWN","Atlantis","Florida","33462",{"type":56,"coordinates":152},[153,154],-80.10088,26.5909,{"lat":154,"lon":153},{"facility":157,"status":49,"city":158,"state":149,"zip":159,"country":53,"countryCode":54,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Mease Countryside Hospital","Clearwater","34695",{"type":56,"coordinates":161},[162,163],-82.8001,27.96585,{"lat":163,"lon":162},[166],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":168,"status":49,"city":169,"state":149,"zip":170,"country":53,"countryCode":54,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"University of Florida, Jacksonville","Jacksonville","32209",{"type":56,"coordinates":172},[173,174],-81.65565,30.33218,{"lat":174,"lon":173},[177],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":179,"status":49,"city":180,"state":149,"zip":181,"country":53,"countryCode":54,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"HCA Largo","Largo","33770",{"type":56,"coordinates":183},[184,185],-82.78842,27.90979,{"lat":185,"lon":184},[188],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":190,"status":49,"city":191,"state":149,"zip":192,"country":53,"countryCode":54,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"AdventHealth Orlando","Orlando","32803",{"type":56,"coordinates":194},[195,196],-81.37924,28.53834,{"lat":196,"lon":195},[199],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":201,"status":49,"city":202,"state":203,"zip":204,"country":53,"countryCode":54,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Atlanta VA","Atlanta","Georgia","30033",{"type":56,"coordinates":206},[207,208],-84.38798,33.749,{"lat":208,"lon":207},[211],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":213,"status":49,"city":202,"state":203,"zip":214,"country":53,"countryCode":54,"cosmosGeoPoint":215,"geoPoint":217,"contacts":218},"Piedmont Heart Institute","30309",{"type":56,"coordinates":216},[207,208],{"lat":208,"lon":207},[219],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":221,"status":49,"city":202,"state":203,"zip":222,"country":53,"countryCode":54,"cosmosGeoPoint":223,"geoPoint":225,"contacts":226},"Emory","30322",{"type":56,"coordinates":224},[207,208],{"lat":208,"lon":207},[227],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":229,"status":49,"city":230,"state":203,"zip":231,"country":53,"countryCode":54,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Archbold Memorial Hospital","Thomasville","31792",{"type":56,"coordinates":233},[234,235],-83.97878,30.83658,{"lat":235,"lon":234},[238],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":240,"status":49,"city":241,"state":242,"zip":243,"country":53,"countryCode":54,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Advocate Good Samaritan Hospital","Downers Grove","Illinois","60515",{"type":56,"coordinates":245},[246,247],-88.01117,41.80892,{"lat":247,"lon":246},[250],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":252,"status":49,"city":253,"state":242,"zip":254,"country":53,"countryCode":54,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Advocate Christ Medical Center","Oak Lawn","60453",{"type":56,"coordinates":256},[257,258],-87.75811,41.71087,{"lat":258,"lon":257},[261],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":263,"status":49,"city":264,"state":265,"zip":266,"country":53,"countryCode":54,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Cardiovascular Research Institute of Kansas","Wichita","Kansas","67226",{"type":56,"coordinates":268},[269,270],-97.33754,37.69224,{"lat":270,"lon":269},[273],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":275,"status":49,"city":276,"state":277,"zip":278,"country":53,"countryCode":54,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Cardiovascular Institute of the South","Houma","Louisiana","70360",{"type":56,"coordinates":280},[281,282],-90.71953,29.59577,{"lat":282,"lon":281},[285],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":287,"status":147,"city":288,"state":289,"zip":290,"country":53,"countryCode":54,"cosmosGeoPoint":291,"geoPoint":295,"contacts":26},"Johns Hopkins","Baltimore","Maryland","21287",{"type":56,"coordinates":292},[293,294],-76.61219,39.29038,{"lat":294,"lon":293},{"facility":297,"status":49,"city":298,"state":299,"zip":300,"country":53,"countryCode":54,"cosmosGeoPoint":301,"geoPoint":305,"contacts":306},"Beth Israel Deaconess","Boston","Massachusetts","02114",{"type":56,"coordinates":302},[303,304],-71.05977,42.35843,{"lat":304,"lon":303},[307],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":309,"status":49,"city":298,"state":299,"zip":300,"country":53,"countryCode":54,"cosmosGeoPoint":310,"geoPoint":312,"contacts":313},"Mass General",{"type":56,"coordinates":311},[303,304],{"lat":304,"lon":303},[314],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":316,"status":49,"city":298,"state":299,"zip":317,"country":53,"countryCode":54,"cosmosGeoPoint":318,"geoPoint":320,"contacts":321},"Brigham & Women's","02115",{"type":56,"coordinates":319},[303,304],{"lat":304,"lon":303},[322],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":324,"status":49,"city":325,"state":299,"zip":326,"country":53,"countryCode":54,"cosmosGeoPoint":327,"geoPoint":331,"contacts":332},"Baystate Medical Center","Springfield","01199",{"type":56,"coordinates":328},[329,330],-72.58981,42.10148,{"lat":330,"lon":329},[333],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":335,"status":49,"city":336,"state":337,"zip":338,"country":53,"countryCode":54,"cosmosGeoPoint":339,"geoPoint":343,"contacts":344},"Minneapolis Heart Institute","Minneapolis","Minnesota","55407",{"type":56,"coordinates":340},[341,342],-93.26384,44.97997,{"lat":342,"lon":341},[345],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":347,"status":49,"city":336,"state":337,"zip":348,"country":53,"countryCode":54,"cosmosGeoPoint":349,"geoPoint":351,"contacts":352},"Minneapolis VA Medical Center","55417",{"type":56,"coordinates":350},[341,342],{"lat":342,"lon":341},[353],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":355,"status":49,"city":356,"state":357,"zip":358,"country":53,"countryCode":54,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"Englewood Health","Englewood","New Jersey","07631",{"type":56,"coordinates":360},[361,362],-73.97264,40.89288,{"lat":362,"lon":361},[365],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":367,"status":49,"city":368,"state":368,"zip":369,"country":53,"countryCode":54,"cosmosGeoPoint":370,"geoPoint":374,"contacts":375},"Icahn School of Medicine at Mount Sinai","New York","10029",{"type":56,"coordinates":371},[372,373],-74.00597,40.71427,{"lat":373,"lon":372},[376],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":378,"status":49,"city":379,"state":380,"zip":381,"country":53,"countryCode":54,"cosmosGeoPoint":382,"geoPoint":386,"contacts":387},"NC Heart and Vascular","Raleigh","North Carolina","27607",{"type":56,"coordinates":383},[384,385],-78.63861,35.7721,{"lat":385,"lon":384},[388],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":390,"status":49,"city":391,"state":392,"zip":393,"country":53,"countryCode":54,"cosmosGeoPoint":394,"geoPoint":398,"contacts":399},"The Lindner Research Center at Christ","Cincinnati","Ohio","45219",{"type":56,"coordinates":395},[396,397],-84.51439,39.12711,{"lat":397,"lon":396},[400],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":402,"status":49,"city":403,"state":404,"zip":405,"country":53,"countryCode":54,"cosmosGeoPoint":406,"geoPoint":410,"contacts":411},"Penn State Health Hershey & Berks","Hershey","Pennsylvania","17033",{"type":56,"coordinates":407},[408,409],-76.65025,40.28592,{"lat":409,"lon":408},[412],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":414,"status":49,"city":415,"state":404,"zip":416,"country":53,"countryCode":54,"cosmosGeoPoint":417,"geoPoint":421,"contacts":422},"UPMC Pinnacle","Mechanicsburg","17050",{"type":56,"coordinates":418},[419,420],-77.00859,40.21426,{"lat":420,"lon":419},[423],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":425,"status":49,"city":426,"state":427,"zip":428,"country":53,"countryCode":54,"cosmosGeoPoint":429,"geoPoint":433,"contacts":434},"Lifespan Rhode Island & Miriam","Providence","Rhode Island","02903",{"type":56,"coordinates":430},[431,432],-71.41283,41.82399,{"lat":432,"lon":431},[435],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":437,"status":49,"city":438,"state":439,"zip":440,"country":53,"countryCode":54,"cosmosGeoPoint":441,"geoPoint":445,"contacts":446},"HCA Centennial","Nashville","Tennessee","37203",{"type":56,"coordinates":442},[443,444],-86.78444,36.16589,{"lat":444,"lon":443},[447],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":449,"status":49,"city":450,"state":451,"zip":452,"country":53,"countryCode":54,"cosmosGeoPoint":453,"geoPoint":457,"contacts":458},"Hendrick Health","Abilene","Texas","79601",{"type":56,"coordinates":454},[455,456],-99.73314,32.44874,{"lat":456,"lon":455},[459],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":461,"status":49,"city":462,"state":451,"zip":463,"country":53,"countryCode":54,"cosmosGeoPoint":464,"geoPoint":468,"contacts":469},"Baylor Scott and White - Dallas","Dallas","75246",{"type":56,"coordinates":465},[466,467],-96.80667,32.78306,{"lat":467,"lon":466},[470],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":472,"status":49,"city":473,"state":451,"zip":474,"country":53,"countryCode":54,"cosmosGeoPoint":475,"geoPoint":479,"contacts":480},"Medical City of Fort Worth","Fort Worth","76104",{"type":56,"coordinates":476},[477,478],-97.32085,32.72541,{"lat":478,"lon":477},[481],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":483,"status":49,"city":484,"state":451,"zip":485,"country":53,"countryCode":54,"cosmosGeoPoint":486,"geoPoint":490,"contacts":491},"Baylor Scott and White Plano","Plano","75093",{"type":56,"coordinates":487},[488,489],-96.69889,33.01984,{"lat":489,"lon":488},[492],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":494,"status":49,"city":495,"state":451,"zip":496,"country":53,"countryCode":54,"cosmosGeoPoint":497,"geoPoint":501,"contacts":502},"Baylor Scott and White - Temple","Temple","76508",{"type":56,"coordinates":498},[499,500],-97.34278,31.09823,{"lat":500,"lon":499},[503],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":505,"status":49,"city":506,"state":507,"zip":508,"country":53,"countryCode":54,"cosmosGeoPoint":509,"geoPoint":513,"contacts":514},"HCA Chippenham","Richmond","Virginia","23225",{"type":56,"coordinates":510},[511,512],-77.46026,37.55376,{"lat":512,"lon":511},[515],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"facility":517,"status":49,"city":518,"state":519,"zip":520,"country":53,"countryCode":54,"cosmosGeoPoint":521,"geoPoint":525,"contacts":526},"Advocate Aurora St. Luke's","Milwaukee","Wisconsin","53215",{"type":56,"coordinates":522},[523,524],-87.90647,43.0389,{"lat":524,"lon":523},[527],{"name":63,"role":39,"phone":26,"phoneExt":26,"email":64},{"type":529,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[531,534],{"name":532,"class":533},"NAMSA","OTHER",{"name":535,"class":6},"Cordis US Corp.","100511990","selution-4-de-novo-small-vessel-ide-trial-100511990",false,"NCT05946629","SELUTION 4 De Novo Small Vessel IDE Trial","A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 PTCA Drug Eluting Balloon in the Treatment of Subjects With De Novo Coronary Lesions in Small Vessels","Inclusion Criteria:\n\n* Clinical Inclusion Criteria\n\nSubjects must meet all of the following clinical criteria to participate in the trial:\n\n1. Subject is ≥ 18 years (or the minimum legal age as required by local regulations).\n2. Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.\n3. Subject presents with chronic coronary syndromes \\[CCS\\] (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for PCI and planned intervention.\n4. Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For subjects requiring oral anticoagulation, aspirin may be omitted based on investigator discretion).\n5. Subject has life expectancy \\> 1 year in the opinion of the investigator.\n6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.\n\nPK Sub- Study Inclusion Criteria:\n\nSubjects must meet all of the main protocol inclusion criteria to participate in the PK sub-study. Subjects must also meet the following additional PK sub-study inclusion criteria:\n\n1\\. Subject is willing and able to provide informed consent for the PK sub-study and comply with the PK sub-study procedures and required follow-up evaluations.\n\nImaging Inclusion Criteria\n\nSubject's target lesion(s) must meet all of the following angiographic criteria for the subject to participate in the trial:\n\n1. A single, target lesions that meet criteria can be treated in a single vessel. No non-target lesions can be treated within the target vessel in the index procedure. Non-target lesions within the target vessel can be staged for treatment \\> 30 days from the index procedure.\n2. Up to two (2) non-target lesions in up to two (2) non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before randomization and treatment of the target lesion.\n3. Target lesion is ≤ 36 mm in length.\n4. Target lesion has diameter stenosis \\> 50% and ≤ 99% with distal flow at least thrombolysis in myocardial infarction (TIMI) 2.\n5. Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm \\[by visual assessment\\].\n6. Target lesion is within a native coronary artery or major branch.\n7. A target lesion within a bifurcation is allowed only if a single vessel (either main vessel or side branch) is to be treated.\n8. The identified target lesion has high probability for successful treatment with approved pre-treatment techniques and DEB alone based on Investigator assessment.\n\nExclusion Criteria:\n\n* Clinical Exclusion Criteria\n\nSubjects who meet any of the following clinical criteria will be excluded from the trial:\n\n1. Subject with known hypersensitivity or allergy to Sirolimus or its analogues.\n2. Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.\n3. Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.\n4. Subject with planned major surgery within 30 days following the index procedure.\n5. Subject with planned treatment of lesion involving aorto-ostial location.\n6. Subject with PCI of a non-target vessel within ± 30 days of the index procedure.\n7. Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure.\n8. Subject with history of active peptic ulcer or gastrointestinal bleeding within 6 months of the index procedure or other inability to comply with the recommended duration of dual antiplatelet therapy (DAPT).\n9. Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure.\n10. Subjects with current documented left ventricular ejection fraction (LVEF) \\\u003C 30%.\n11. Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated.\n12. Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.\n13. Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure.\n14. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \\[GFR\\] ≤ 30 ml\u002Fmin\u002F1.73 m2 within 30 days of index procedure) or had undergone renal transplantation.\n\nPK Sub-Study Exclusion Criteria:\n\nSubjects must meet none of the main protocol exclusion criteria to participate in the PK sub-study. Subjects will be excluded if any of the following additional PK sub-study exclusion criteria are met:\n\n1. Any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device has been placed\u002Fused in any part of the body within 3 months prior to the index procedure including non-target lesion(s) treated during the index procedure.\n2. Planned intervention with any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device anywhere in the body within 6 months after the index procedure. Note: staged procedures \\>30 days after index procedure (Exclusion #6 of the main protocol) are permitted only in the main protocol, and are not permitted in this PK sub-study.\n3. The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason.\n4. Subject is concurrently enrolled in the main protocol angiographic registry.\n5. Subjects who are taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plan to take the strong inhibitors during the study period. Strong inhibitors include: cobicistat; ritonavir; indinavir and ritonavir; itraconazole; ketoconazole; lopinavir and ritonavir; paritaprevir and ritonavir and ombitasvir (and\u002For dasabuvir); posaconazole; saquinavir and ritonavir; tipranavir and ritonavir; elvitegravir and ritonavir; telithromycin; voriconazole; ceritinib; clarithromycin; idealalisib; nefazodone; nelfinavir.\n6. Subjects who are taking strong CYP3A4 Inducers within 14 days before the index procedure or plan to take the strong inducers during the study period. Strong inducers include apalutamide; carbamazepine; enzalutamide; ivosidenib; lumacaftor and ivacaftor; mitotane; phenytoin; rifampin; St. John's wort.\n\n   * Angiographic Exclusion Criteria\n\nSubject whose target lesion(s) meet any of the following angiographic criteria will be excluded from the trial:\n\n1. Target lesion is totally occluded or has evidence of thrombus.\n2. Target lesion is located in the left main or any arterial or venous graft.\n3. Target lesion is in a side branch that is \"jailed\" by a main vessel stent.\n4. In stent restenosis","ALL","18 Years",{"count":546,"type":547},960,"ESTIMATED","INTERVENTIONAL",[550],"NA","Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA.\n\nThe Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.",[553],"Coronary Artery Disease",[555,556,557,558,559,560,561,562,563,564,565,566],"CAD","DCB","DEB","NSTEMI","Stable Angina","Chronic Coronary Syndrome","CCS","Drug Coated Balloons","Drug Eluting Balloons","Small Vessels","SELUTIONSLR","Sirolimus","2025-09-25",{"date":569,"type":570},"2025-09-29","ACTUAL",{"date":572,"type":570},"2023-10-20",{"date":574,"type":547},"2031-06",{"name":5,"class":6},43]