A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.
Peripheral Arterial DiseaseEvaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.
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).
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.
Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA...
Peripheral Arterial Disease (PAD)The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.
A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral...
Peripheral Vascular DiseaseOSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a superficial femoral artery (SFA) stent procedure using the Misago™ Peripheral Self Expanding stent once all of the inclusion and none of the exclusion criteria are met. The stent efficacy and safety will be evaluated immediately post procedure, and at 30 days, 6, 12, 24, and 36 months post procedure. A subject is considered enrolled into the OSPREY study after he/she signs the informed consent and meets all inclusion/exclusion criteria. The study objectives are to demonstrate that efficacy and safety of this novel stent design are not inferior to historical Percutaneous Transluminal Angioplasty (PTA) and stent outcomes and meet the performance goals as published in the objective performance goals by Rocha-Singh, et al. This is a multi-center, single arm, non-randomized, prospective clinical trial of the Misago™ Self-Expanding Stent System for the treatment of atherosclerotic stenosis and occlusions of the SFA. The primary endpoint of stent patency will be evaluated at 12 months.
The Jetstream (JET) Post-market Registry
Peripheral Arterial DiseasesThe scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.
The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
Endothelial DysfunctionInsulin Resistance2 moreThe purpose of this study are twofold: To understand the effects of physical inactivity (sedentarism) on vascular function, insulin resistance and inflammation; To assess the role of a dietary intervention (fish oil) in counteracting the effects of physical inactivity on vascular function and inflammation.