[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576192":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":44,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"The Methodist Hospital Research Institute","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Amputation Arm",null,"In an ex vivo human cadaveric model, post-PVI histopathologic analysis will be used to uncover the impact of plaque type on device safety (POBA versus atherectomy) and performance, facilitating evidence-based device selection to mitigate complications. Using a randomized approach, the investigator will compare plain balloon angioplasty to orbital atherectomy prior to angioplasty in amputated legs from PAD patients with plaques characterized into 4 categories based their MRI-histology: concentric calcium, eccentric calcium, fibrous plaque, and soft plaques (smooth muscle and thrombus).",{"label":13,"type":10,"description":14,"interventionNames":10},"Revascularization Arm","Patient Imaging Protocol: Scans will be performed on 100 patients enrolled into the study population using a 3T MAGNETOM scanner (Siemens) at the Houston Methodist Research Institute Translational Imaging Center. The investigator will use pre-operative images captured using the optimized MRI-histology sequences to score lesions. Physicians performing PVI will be blinded to the pre-operative MRI-histology images and anatomic scores and will make treatment decisions based on their standard of care. The investigator expect MRI-histology plaque scores predict which patients will have PVI failures due to untraversable plaque, and it may also foresee the potential need of adjunctive devices or alternative approaches for successful PVI",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Trisha Roy, MD, PhD","CONTACT","713-441-5200","troy@houstonmethodist.org",[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Houston Methodist Hospital","RECRUITING","Houston","Texas","77030","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-95.36327,29.76328,{"lat":34,"lon":33},[37,38,42],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},{"name":39,"role":18,"phone":40,"phoneExt":10,"email":41},"Janak Lamichhane, MBBS, MBA","346- 238-2291","jlamichhane@houstonmethodist.org",{"name":17,"role":43,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":43,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Triisha Roy","Vascular Surgeon- Scientist",[48],{"name":49,"class":50},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100576192","mri-guided-management-of-occlusive-peripheral-arterial-disease-100576192",false,"NCT06782100","MRI Guided Management of Occlusive Peripheral Arterial Disease","Inclusion Criteria:\n\nA. General Inclusion Criteria:\n\ni. All patients will be ≥ 18 years old with PAD (Rutherford Category 4, 5, 6)\n\nB. Anatomic inclusion criteria:\n\ni. At least 1 target lesion below-the-knee in native vessels in one or both limbs ii. Target lesion reference vessel diameter between 2.0 - 4.0 mm by investigator visual estimate iii. Target lesion with \\> 50% stenosis by investigator visual estimate\n\nExclusion Criteria:\n\nA. General Exclusion Criteria:\n\ni. Rutherford category 0, 1, 2, 3 of target limb, Failure or refusal to provide written informed consent, MRI Contraindications\n\nB. Anatomic Exclusion Criteria:\n\nii. Aim 2 only - Chronic total occlusions","ALL","18 Years",{"count":60,"type":61},175,"ESTIMATED","12 Months","OBSERVATIONAL","The goal of this observational study is to identify which plaque lesions in patients with peripheral arterial disease are impenetrable and to determine which devices minimize vessel wall injury.\n\nPatients undergoing intervention will have an MRI scan prior to their planned percutaneous vascular intervention to assess the plaque and predict procedural difficulty.\n\nPatients undergoing lower limb amputation due to peripheral arterial disease will have their limbs included into a second arm of the study The limb will undergo an MRI scan to assess the plaque. The investigator will then test two different devices and assess the effects of these devices on the vessel wall.",[66],"Peripheral Vascular Diseases",[55,68,69,70,71,72],"PAD","Peripheral Vascular Disease","PVI","MRI","MRA","2026-03-16",{"date":75,"type":76},"2026-03-19","ACTUAL",{"date":78,"type":76},"2024-07-01",{"date":80,"type":61},"2029-06",{"name":5,"class":6},1]