ILLUMENATE EU Randomized Clinical Trial
Peripheral Arterial DiseaseClaudicationThis is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Peripheral Arterial DiseaseCohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries. Cohort 2: To evaluate this patient population for treatment of in-stent restenotic lesions.
Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal...
Peripheral Artery DiseaseTo describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or restenotic lesion(s), occluded/stenotic or re-occluded/restenotic lesion(s).
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
IschemiaPeripheral Arterial Disease1 moreThis study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)
A Study to Evaluate the Efficacy and Safety of Pletaal SR Capsule (Cilostazol) in Subjects With...
Chronic Occlusive Arterial DiseaseThis study is to evaluate symptomatic changes and safety before and after the administration of Pletaal® SR Capsules based on Peripheral Artery Questionnaire (PAQ) in subjects with peripheral arterial disease symptom due to chronic occlusive arterial disease (COAD).
EverFlex Post Approval Study
Peripheral Arterial DiseaseLower Extremity Arterial DiseaseThis post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.
Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)
Intermittent ClaudicationPeripheral Artery DiseaseThe 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: Double treatment of PLX-PAD low dose Double treatment of PLX-PAD high dose Double treatment of Placebo 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
LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)
Peripheral Artery DiseaseThe purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.
Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent to Treat BTK Arteries
Peripheral Arterial DiseaseThe objective of this clinical study is to evaluate the immediate and long-term (up to 12 month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the treatment of patients with critical limb ischemia (i.e. rest pain or non-healing foot ulcers) due to the presence of arterial lesions in the below-the-knee arteries of maximally 50mm long.
BIOLUX P-I First in Man Study
AtherosclerosisArteriosclerosis2 moreA prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.