View clinical trials related to Peripheral Artery Disease.
Filter by:The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.
The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.
The purpose of the investigators study is to examine and compare primary patency between balloon expandable cobalt chromium stent and self expandable nitinol stents (SCUBA versus COMPLETE-SE) in atherosclerotic iliac artery lesion.
The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.
There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number of these patients could be helped through medication or surgery. In fact within the first year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90% have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases 3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year primary patency rates up to 30%. The primary objective of this study is to compare the performance of atherectomy followed by a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo infrapopliteal lesions in a prospective, single-center, randomized clinical trial.
Iodinated contrast is the current gold standard for infrainguinal angiography imaging in patients without renal insufficiency and has also been used with intravascular Optical Coherence Tomography (iOCT) to improve image quality in human coronary arteries as well as carotid arteries. The current debate in the literature for iOCT medium is between iodinated contrast and dextran and CO2 may offer a superior method of iOCT imaging during lower extremity occlusive disease interventions. The investigators hypothesize that the CO2 medium injection during iOCT data acquisition is feasible and will produce at least the same quality of imaging as that obtained with contrast or dextran without causing the problems of volume overload and renal toxicity seen with the two latter mediums. Primary Outcomes Measured - Quality: Cumulative number of clear image frame (CIF) through the entire 54mm length segment. - Quantitative: Calculations of the area and diameter of each segment will be measured to determine if index of refraction has any effect between the three mediums to be tested. The investigators expect to find little difference between all three iOCT mediums and hope to conclude that CO2 offers a superior side effect profile for iOCT imaging in the lower extremity arterial system.
The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.
Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to paclitaxel-eluting balloons for treating symptomatic peripheral artery disease of the femoropopliteal artery.
The objective of the study is to establish the safety profile of Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects comprising of 4 treatment groups: 1. Double treatment of PLX-PAD low dose 2. Double treatment of PLX-PAD high dose 3. Double treatment of Placebo 4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will receive the assigned treatment twice to the affected leg, within 12-weeks interval between each treatment. The study will be comprised of 5 stages: Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by additional injection after 12 weeks and with follow-up of 12 months post second injection
The primary purpose of this study is to assess safety and efficacy of the Drug Eluting Balloon (DEB) technology for the treatment of the Superficial Femoral Artery (SFA) ischemic obstructive vascular disease in patients presenting with long lesions. As secondary aim this study is going to explore treatment effect on a number of procedural and clinical endpoints in order to collect information to design a future comparative effectiveness study.