Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent
Peripheral Arterial DiseasesSuperficial Femoral Artery StenosisThe intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in patients with superficial femoral/ popliteal artery disease. 100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study and shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which time the stent will be placed, and follow-up visits at 6 and 12 months. Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will be efficacious in patients with Superficial Femoro/Popliteal Artery disease.
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar...
Peripheral Artery DiseasePeripheral Vascular DiseaseThe objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.
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).
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.
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
Evaluation of Paclitaxel Eluting Stent vs Paclitaxel Eluting Balloon Treating Peripheral Artery...
Peripheral Artery DiseaseObjective 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.
LEVANT 2 Safety Registry
Peripheral Artery DiseaseFemoropopliteal Artery Occlusion1 moreThe 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.
Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH)...
Peripheral Artery DiseaseThe purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal ("balloon") angioplasty and stent placement for the treatment of peripheral artery disease (PAD).