[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rede Optimus Hospitalar SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":147},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,55,82,105,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":4},"100624364","compete-lm-trial-drug-coated-balloon-enhanced-provisional-stenting-in-complex-left-main-disease-100624364",false,"NCT07408674","COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease.","The COMPETE-LM Trial: A Physician-initiated Randomized Clinical Trial (RCT) Comparing Conventional Provisional Stenting With Drug-coated Balloon-enhanced Provisional Stenting for the Treatment of Complex Left Main (LM) Coronary Artery Disease.","COMPETE-LM","Inclusion Criteria:\n\n1. Distal left main stem bifurcation stenosis type Medina 1,1,1 or 0,1,1 with indication for revascularization.\n2. Left main diameter ≤6.00 mm.\n3. LAD and LCx diameter both \\>2.75 mm, evaluated by visual estimation.\n\nExclusion Criteria:\n\n1. Subjects with ages 18 or below at the time of the procedure.\n2. Female subjects who may be pregnant or breast-feeding at the time of the procedure.\n3. Previous PCI of the left main bifurcation.\n4. Chronic total occlusion of the LAD or LCx.\n5. Trifurcating left main requiring treatment of the 3 branches.\n6. LAD and LCx reference sizes are out of the sizing ranges of the used DES\u002FDCB families.\n7. In-stent restenosis as target lesion.\n8. Previous coronary artery bypass graft (CABG) with any patent graft on the left coronary system.\n9. ACS-STEMI (ST-Segment Elevation Myocardial Infarction) due to LM disease.\n10. Cardiogenic shock.\n11. Left ventricular ejection fraction below 35%.\n12. Decision to use mechanical circulatory support for protected PCI.\n13. Contraindication to a minimum of 3 months double antiplatelet and long-term single antiplatelet therapy (or adapted, in case of indication for anticoagulation).\n14. Associated significant valvular disease.\n15. Renal insufficiency with glomerular filtration rate (GFR) \\\u003C 20.\n16. Life expectancy less than one year.","ALL","18 Years",{"count":20,"type":21},186,"ESTIMATED","INTERVENTIONAL",[24],"NA","Prospective, physician-initiated, multicenter, randomized, single-blind, controlled trial.\n\nParticipants will be randomized (1:1) to a DCB-enhanced strategy (study group) or a conventional strategy (control group).\n\nThe study aims to compare the clinical outcomes of conventional provisional stenting (Angiolite in the main branch, with optional side branch stenting if compromised) versus DCB enhanced provisional stenting (Angiolite in the main branch plus Essential Pro in the side branch) in patients with complex left main bifurcation stenosis indicated to receive non-urgent percutaneous coronary intervention (PCI).\n\nTarget lesions, both main vessel and side branch, will be treated using iVascular devices, with patients randomized into two arms. In one arm, treatment will be performed exclusively with the Angiolite sirolimus-eluting stent (Angiolite, iVascular) in the main vessel, while in the other arm, the Angiolite will be used in the main vessel and the Essential Pro paclitaxel drug-eluting balloon (Essential Pro, iVascular) in the side branch. Non-target lesions may be treated with any commercially available devices according to their approved indications.",[27,28,29],"Complex Left Main Bifurcation Stenosis","Left Main Coronary Artery Stenosis","Coronary Bifurcation Stenosis",[31,32,33,28,34,35,36,37,38,39,40,41,42],"Essential Pro Paclitaxel","Angiolite","Left Main Artery","Left Main Coronary Artery","Left Main Bifurcation Stenosis","Coronary Disease","Coronary Artery Disease","Complex Left Main Disease","Drug Eluting Balloon","Drug Coated Balloon","Provisional Stenting","Sirolimus Eluting Stent","NOT_YET_RECRUITING","2026-02-06",{"date":46,"type":47},"2026-02-13","ACTUAL",{"date":49,"type":21},"2026-04",{"date":51,"type":21},"2029-05",{"name":53,"class":54},"Rede Optimus Hospitalar SA","NETWORK",{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100585109","transfemoral-tavi-with-or-without-coronary-angiogram-in-patients-with-severe-aortic-stenosis-pure-tavi-100585109","NCT06898086","Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI)","Treatment of Severe Aortic Stenosis With Transfemoral TAVI With or Without Coronary Angiogram During Diagnostic Work-up (PURE TAVI)","PURETAVI","Inclusion Criteria:\n\n* Patient is older than 18 years with severe AS considered for TAVI by a multidisciplinary heart team.\n* Patient is candidate for transfemoral TAVI as per local standards and current guidelines.\n* Patient is willing and capable to give written consent to participate to the trial and confirmed to be able to attend the expected follow up visits.\n\nExclusion Criteria:\n\n* Patient had a coronary angiogram with or without PCI and\u002For coronary CT and\u002For CABG within last 5 years.\n* Left main PCI in the medical history\n* Patient has CCS of 3 or more.\n* Patient has left ventricular ejection fraction \\\u003C30%.\n* Patients in whom TAVI through femoral access is ad priori not possible based on clinical assessment or medical history\n* Patient has been treated for acute myocardial infarction within 30 days before randomization.\n* Patient has a planned open-heart surgery.\n* Patient has a life expectancy less than 1 year due to other severe non-cardiac disease.\n* Patient is participating in another clinical study with an investigational product that has not yet completed the follow up period.\n* Patient has received previous treatment for aortic valve implantation or replacement.\n* Female patient who is pregnant at the time of inclusion and female patient of childbearing potential","120 Years",{"count":65,"type":21},620,[24],"This study will be conducted in patients with severe aortic stenosis who are referred for transcatheter aortic valve implantation (TAVI). TAVI is the recommended treatment for severe aortic stenosis. Currently, before undergoing TAVI, most patients undergo a coronary angiography to check whether the coronary arteries are blocked and to assist in appropriate valve sizing. If significant blockages are detected, they are treated before or during TAVI.\n\nHowever, many patients who undergo TAVI are older and often have additional cardiovascular conditions such as hypertension, diabetes, or obesity. These comorbidities increase the risk of complications related to coronary angiography, including kidney injury from contrast dye, bleeding, and vascular complications at the access site. As such, it remains uncertain whether routine coronary angiography is necessary for all patients undergoing TAVI, particularly those without symptoms suggestive of myocardial ischemia.\n\nThis study aims to determine whether a TAVI treatment pathway without prior coronary angiography is non-inferior to the standard pathway that includes routine coronary angiography, with or without revascularization, in patients with severe aortic stenosis who do not have typical angina symptoms (defined as Canadian Cardiovascular Society Class \\\u003C3). \"Non-inferior\" means the study seeks to show that omitting routine coronary angiography is at least as effective and safe as the standard approach.\n\nAll participants will receive a CE-certified Myval™ balloon-expandable transcatheter heart valve. This device is commercially available and designed to provide accurate positioning and reliable valve function.\n\nThis is a multicentre, investigator-initiated clinical study sponsored by Rede Optimus (RO), Alte Steinhauserstrasse 1, 6330 Cham, Switzerland. RO conducts independent research to address unresolved questions in vascular medicine. The study is financially supported by Meril Life Sciences Pvt. Ltd., Bilakhia House, Survey No.135\u002F139, Muktanand Marg, Chala, Vapi 396191, Gujarat, India.\n\nApproximately 620 patients will be enrolled across 20 centres in 7 European countries. The total study duration is expected to be 42 months, with an 18-month enrollment period and 24-month follow-up for each participant.",[69],"Severe Aortic Stenosis",[71],"PURE TAVI","RECRUITING","2026-02-04",{"date":75,"type":47},"2026-02-09",{"date":77,"type":47},"2025-08-08",{"date":79,"type":21},"2028-10-30",{"name":53,"class":54},23,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":5},"100541672","shockwaveperipheral-intravascular-lithotripsy-balloon-for-advanced-endovascular-aortic-repair-100541672","NCT06332911","Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair","International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair","TEVAR","Inclusion Criteria:\n\n1. Patient (m\u002Ff) age ≥ 18 years at time of enrollment.\n2. Diagnosis of thoracic and\u002For thoraco-abdominal (Extent I-V) and juxta\u002Fpara-renal\u002Fshort-neck aneurysm requiring the implantation of a thoracic and\u002For thoraco-abdominal fenestrated\u002Fbranched aortic endograft with delivery system introducer sheath diameter equal or larger than 18 Fr (6 mm).\n3. Hostile iliac access was defined in the presence of:\n\n   * Heavily circumferential calcified iliac arteries\n   * Inner diameter ≤ 6 mm\n   * Severe stenosis (\\> 50%; \\> 2.5 m\u002Fs peak velocity; absence of triphasic duplex signal in ipsilateral common femoral artery)\n4. We will accept the following presentations of aneurysm:\n\n   * urgent cases,\n   * elective,\n   * symptomatic\n   * and fast growing.\n5. The repair was performed using Shockwave™ before the introduction of the main endograft. The iliac procedures can be accompanied by angioplasty and\u002For stent and stent-graft positioning.\n\nExclusion Criteria:\n\n1. Patients submitted to surgical conduit bypass.\n2. Not-severely calcified disease (absence of calcification).\n3. In-stent restenosis\u002Focclusion.\n4. Inability to cross with 0.014 guidewire.\n5. Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study.\n6. Pre-stented iliac access vessels at the level of Shockwave implementation.",{"count":91,"type":21},30,"OBSERVATIONAL","Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.\n\nThe aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F\u002FBEVAR.",[95,96,97],"Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture","Abdominal Aortic Aneurysm Without Rupture","Thoracic Aortic Aneurysm Without Rupture","2025-05-19",{"date":100,"type":47},"2025-05-23",{"date":98,"type":47},{"date":103,"type":21},"2027-05-30",{"name":53,"class":54},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":5},"100506396","trans-femoral-access-intravascular-lithotripsy-comparison-with-pta-in-tavi-100506396","NCT05873842","TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI","TRAFIC-PTA","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Written informed consent\n3. Diagnosis of symptomatic severe aortic stenosis\n4. Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion.\n5. High-quality Contrast-enhanced ECG gated computed tomography (CT) scan of the heart, aorta and low-limb arteries\n6. Calcific severe PAD raising concerns within the Heart Team and judged as \"arguable\" for TF approach following angiography or CT-scan evaluation (hostile femoral access), with a RefD\\>\u002F=5 mm and a MLD\\>\u002F=3 mm.\n7. Hostility score \\>\u002F= 23 in at least one segment of the axis under evaluation.\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C 1 year\n2. Subject has active infection requiring antibiotic therapy.\n3. STS score ≥8%\n4. Leriche syndrome or other forms of total occlusion of the aorta or both iliac axes.\n5. Planned target limb major amputation (above the ankle).\n6. History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.\n7. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.\n8. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.\n9. Subject has known allergy to urethane, nylon, or silicone.\n10. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.\n11. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.\n12. The use of specialty balloons, re-entry or atherectomy devices",{"count":113,"type":21},50,"To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.",[116],"Trans-femoral TAVI With Calcified Ilio-femoral Arteries",[118,119,120],"TAVI","Calcification","Ilio-femoral arteries","2025-05-13",{"date":123,"type":47},"2025-05-16",{"date":125,"type":47},"2024-07-22",{"date":127,"type":21},"2026-11-01",{"name":53,"class":54},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100487354","shockwave-ivl--dcb-100487354","NCT05625997","Shockwave IVL + DCB","Intravascular Lithotripsy Plus Drug-coated Balloon in Calcified Small Coronary Vessels: a Feasibility Exploratory Study","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Coronary artery disease with percutaneous intervention clinically indicated to treat one or more lesions fulfilling all criteria below:\n\n   * De novo lesion with diameter stenosis \\> 50% (visual analysis)\n   * Coronary vessel diameter \\\u003C 3.0 mm (visual analysis)\n   * Severe calcification at the target segment, defined as fluoroscopic radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least 1 location OR Intravascular Ultrasound\u002FOptical Coherence Tomography (IVUS\u002FOCT) demonstrated calcium angle of ≥270° on at least 1 cross section.\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Previous coronary intervention at or \\\u003C 10 mm distant from target segment at any time.\n2. Lesion length ≥ 40 mm.\n3. Planned atherectomy or cutting\u002Fscoring balloon use.\n4. Bifurcation lesion.\n5. Thrombus containing lesion.\n6. Life expectancy \\\u003C 12 months due to other co-morbid condition(s) that could limit patient's ability to participate in clinical study",{"count":113,"type":21},"Drug-eluting stent (DES) implantation as interventional strategy for lesions in small coronary arteries is the current standard of care in many centers worldwide, but is associated with increased risk of late treatment failure in small vessels, as compared with larger coronary arteries. Randomized and observational studies have been shown that coronary intervention with drug-coated balloons (DCB) provide a promising alternative to DES implantation in small vessels, while avoiding the risk of a permanent vascular implant. Furthermore, lesions in small vessels are frequently concomitant with diffuse disease and\u002For distal location, where the presence of calcification is an additional common feature. Intravascular lithotripsy (IVL) has been recently introduced as a novel adjunctive technology to treat calcified lesions.\n\nThis study will explore the hypothesis that IVL has the potential to enhance the results of coronary balloon dilatation of small vessels with calcified lesions, therefore increasing the likelihood of optimal DBC intervention.",[139],"Calcified Lesions in Small Coronary Vessels",{"date":123,"type":47},{"date":142,"type":47},"2023-06-16",{"date":144,"type":21},"2026-06-30",{"name":53,"class":54},2,""]