Clinical trials: Femoral Artery Occlusion
Peripheral Artery Disease, Peripheral Vascular Disease
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
The 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…
- Trial name
- BIOFLEX-I (NCT01319812)
- Testing
- Astron Stents, Pulsar Stents
- Where
- 35 sites in United States, Canada
- Volunteers
- 463 people
- Sponsor
- Biotronik, Inc.
Femoral Artery Stenosis, Popliteal Artery Stenosis
MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- MDT-2113 SFA (NCT01947478)
- Testing
- MDT-2113 Drug-Eluting Balloon, Standard angioplasty balloon
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Medtronic Endovascular
Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis
Preliminary Exploration of Factors Affecting Complete Hemostasis and Supine Time After Removal of Femoral Arterial Sheath in ICU Patients
Background:Following cardiac catheterization and arterial sheath removal, manual compression is applied until bleeding stops, after which a compression belt is used.
- Conditions
- Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis, Coronary Artery Disease, Percutaneous Coronary Intervention
- Trial name
- NCT07469397
- Testing
- Direct Inspection, medical records browsing
- Where
- Taiwan
- Volunteers
- 157 people
- Sponsor
- National Taiwan University Hospital
Atherosclerosis, Ischemia Limb
Efficacy and Safety Comparison of the Open Surgical and Endovascular Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D.
Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006).
- Conditions
- Atherosclerosis, Ischemia Limb, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- NCT04588571
- Testing
- Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stent, Femoropopliteal proximal bypass
- Where
- Russia
- Volunteers
- 110 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Atherosclerosis of Native Arteries of the Extremities, Unspecified
SuperNOVA Clinical Stenting Trial
The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.
- Trial name
- NCT01292928
- Testing
- Stent implantation
- Where
- 49 sites in United States, Austria and 5 more
- Volunteers
- 299 people
- Sponsor
- Boston Scientific Corporation
Atherosclerosis, Peripheral Vascular Disease
A Safety and Efficacy Study of the Dynalink®-E Everolimus Eluting Peripheral Stent System
The purpose of this first-in-man study is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native…
- Trial name
- STRIDES (NCT00475566)
- Testing
- Dynalink®-E everolimus-eluting peripheral stent, Dynalink®-E, everolimus-eluting peripheral stent
- Where
- 10 sites in Austria, Belgium and 2 more
- Volunteers
- 104 people
- Sponsor
- Abbott Medical Devices
Femoral Artery Stenosis, Angioplasty
an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions
This is a prospective, single-center, single-arm, observational study. It plans to enroll 58 patients with moderate to severely calcified lesions in the femoropopliteal or infrapopliteal arteries.
- Conditions
- Femoral Artery Stenosis, Angioplasty, Cutting Balloon Angioplasty, Calcifications, Vascular
- Trial name
- DkuLL CALVEP (NCT07397390)
- Testing
- DKutting LL scoring balloon angioplasty
- Where
- China
- Volunteers
- 58 people
- Sponsor
- The First Affiliated Hospital of Dalian Medical University
Peripheral Artery Disease
A Study of the SMART Stent in the Treatment SFA Disease.
The main objective of this study is to assess the safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral…
- Trial name
- SIROCCO (NCT00232869)
- Testing
- drug-eluting stent, bare-metal stent
- Where
- Germany
- Volunteers
- 93 people
- Sponsor
- Cordis US Corp.
Peripheral Vascular Disease
Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions and Restenosis From Prior Endovascular Procedures in This Sector.
The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting balloon luminor 14 \& luminor 35 in the treatment of infrainguinal occlusive lesions (superficial femoral artery (SFA), popliteal artery…
- Trial name
- NCT02458911
- Testing
- Paclitaxel-eluting balloon
- Where
- Spain
- Volunteers
- 214 people
- Sponsor
- iVascular S.L.U.
Peripheral Arterial Disease
PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE
To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the superficial femoral and popliteal arteries.
- Trial name
- PRELUDE (NCT03001700)
- Testing
- Serranator™ Alto PTA Serration Balloon Catheter
- Where
- 4 sites in Austria, New Zealand and 1 more
- Volunteers
- 25 people
- Sponsor
- Cagent Vascular LLC
Peripheral Arterial Disease
A Study Evaluating the Endovascular Treatment of Subjects With Stenotic or Restenotic Lesions of the Common Femoral Artery With the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy
The SUPERSURG RCT trial investigates the efficacy and safety of the endovascular treatment of stenosis or restenosis in the common femoral artery (CFA) of patients presenting with Rutherford classification 2,3 or 4 with a Supera…
- Trial name
- SUPERSURG-RCT (NCT04349657)
- Testing
- Supera Peripheral Stent System treatment group, Endarterectomy treatment group
- Where
- 13 sites in Belgium, Netherlands and 1 more
- Volunteers
- 286 people
- Sponsor
- KANDO Research
Atherosclerosis of Native Arteries of the Extremities
ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent
The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA)…
- Trial name
- IMPERIAL (NCT02574481)
- Testing
- ELUVIA (Stent Implantation), Zilver PTX (Stent Implantation)
- Where
- 68 sites in United States, Austria and 5 more
- Volunteers
- 524 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease
Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon
This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.
- Trial name
- ILLUMENATE (NCT01858428)
- Testing
- Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter, EverCross Percutaneous Transluminal Balloon Catheter
- Where
- 44 sites in United States, Austria
- Volunteers
- 300 people
- Sponsor
- Spectranetics Corporation
Common Femoral Artery Occlusive Disease
A Prospective, Multicenter, Observational Study on the Treatment of Chronic Common Femoral Artery Bifurcation Occlusion
This study is a prospective, multicenter real-world observational study to understand the safety and efficacy of endoluminal therapy and traditional endometristomy in the real world for patients with severe stenosis and occlusion…
- Trial name
- EAST-CFA (NCT05603546)
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Qingdao Hiser Medical Group
Peripheral Arterial Disease
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Cohort 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…
- Trial name
- ILLUMENATE (NCT01927068)
- Testing
- Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)
- Where
- 44 sites in Australia, Austria and 8 more
- Volunteers
- 499 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)
The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral…
- Trial name
- NCT03847233
- Testing
- Jetstream Atherectomy System
- Where
- 5 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Boston Scientific Corporation
Artery Stenosis, Carotid, Artery Stenosis
A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population.
- Conditions
- Artery Stenosis, Carotid, Artery Stenosis, Occlusion of Artery, Stroke
- Trial name
- NCT04643743
- Testing
- Endarterectomy
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Perouse Medical
Peripheral Arterial Disease
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)
The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral…
- Trial name
- NCT02733653
- Testing
- Jetstream Atherectomy System
- Where
- 10 sites in Japan
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease
The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study
The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial…
- Trial name
- TORUS2 (NCT04130737)
- Testing
- TORUS Stent Graft System
- Where
- 32 sites in United States
- Volunteers
- 188 people
- Sponsor
- Endologix
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Shockwave IVL + DES
The objective of this clinical investigation is to evaluate, in a controlled setting, the 12 months safety and efficacy of the combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device, for…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Calcifications Vascular
- Trial name
- Shockwave DES (NCT05291247)
- Testing
- Peripheral lithotripsy system (Shockwave Medical)
- Where
- 6 sites in Germany
- Volunteers
- 50 people
- Sponsor
- Marc Bosiers, MD