Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System
Peripheral Arterial DiseaseTo demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm, multicenter clinical trial.
First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of...
Peripheral Artery DiseaseFemoropopliteal Artery DiseaseThe purpose of this pivotal, first in man study will be to evaluate safety and efficacy of the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment of femoropopliteal artery disease.
Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System
Peripheral Vascular DiseaseThe objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the BeGraft Peripheral Stent Graft System (Bentley InnoMed) in clincial settings post CE-certification when used according to the indications of the IFU.
Prospective, Non-randomized Multi-center, Controlled Physician-initiated Trial: Rotarex Belgium...
Peripheral Vascular DiseaseThe objective of this study is to evaluate the safety and efficacy of recanalization of acute and subacute femoropopliteal stent occlusions with the Rotarex S catheter (Straub Medical)
AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China
Peripheral Artery DiseaseThe purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.
BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease...
Peripheral Artery DiseasePeripheral Vascular Disease1 moreCollect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.
Zilver Flex Post-Market Study in Japan
Peripheral Arterial Disease (PAD)Japanese post market clinical study of the Zilver Flex device.
Zilver PTX Post-Market Study in Japan
Peripheral Arterial Disease (PAD)Japanese post market clinical study of the Zilver PTX device.
Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization...
Peripheral Arterial DiseaseThe purpose of this study is to test if dexamethasone, an anti-inflammatory medication approved by the US Food and Drug Administration (FDA), can be injected safely into the tissue around the blood vessel wall at the time of an angioplasty or atherectomy.
Endovascular Atherectomy Safety and Effectiveness Study
Peripheral Vascular DiseaseThe purpose of this study is to evaluate the procedural safety and effectiveness of the Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic lesions located in the native peripheral arteries. The Phoenix Atherectomy™ System is intended for use in atherectomy of the peripheral vasculature. The intended peripheral vessels include the Superficial Femoral, Popliteal, and Infrapopliteal arteries. The system is not intended for use in the coronary, carotid, iliac or renal vasculature. The results of this study will be used to support a 510(k) submission to the Food and Drug Administration.