Clinical trials: Peripheral Arterial Occlusive Disease
Peripheral Arterial Disease
Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions
This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion.
- Trial name
- NCT07049120
- Testing
- ZENFLEX Pro™ Peripheral Drug-eluting Stent System
- Where
- Poland
- Volunteers
- 153 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function.
- Trial name
- NCT06383390
- Testing
- Retatrutide
- Where
- 742 sites in United States, Argentina and 25 more
- Volunteers
- 10,000 people
- Sponsor
- Eli Lilly and Company
Peripheral Arterial Disease
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter…
- Trial name
- TOBA II BTK (NCT02942966)
- Testing
- Tack Endovascular System
- Where
- 49 sites in United States, Austria and 4 more
- Volunteers
- 233 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Peripheral Arterial Disease (PAD)
Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
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…
- Trial name
- INPACT SFA I (NCT01175850)
- Testing
- Drug-Coated Balloon (DCB), PTA Balloon: Balloon Angioplasty
- Where
- Germany
- Volunteers
- 331 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease
VITUS Post-Market Registry
To collect post marketing surveillance data on consecutive patients with peripheral arterial occlusive disease (PAOD) intended to be or treated by the VITUS peripheral drug-coated dilatation catheter when used according to the…
- Trial name
- NCT06832631
- Testing
- Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 283 people
- Sponsor
- OrbusNeich
Peripheral Arterial Disease, Peripheral Artery Disease
Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries
The objective of this early feasibility study is to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter.
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Stenosis Artery
- Trial name
- PREVISION (NCT05556681)
- Testing
- BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty
- Where
- 10 sites in Australia, New Zealand and 1 more
- Volunteers
- 34 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease
Soundbite Crossing System Peripheral First in Man
This is a clinical study aimed at demonstrating the safety and product performance of the SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System can facilitate passage of a standard guidewire…
- Trial name
- NCT03013088
- Testing
- CTO Crossing
- Where
- 2 sites in Canada
- Volunteers
- 37 people
- Sponsor
- SoundBite Medical Solutions, Inc.
Peripheral Arterial Occlusive Disease
Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)
The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries.
- Trial name
- CONSEQUENT (NCT02460042)
- Testing
- drug coated balloon angioplasty, SeQuent® Please OTW Paclitaxel Coated Balloon Catheter
- Where
- Germany
- Volunteers
- 960 people
- Sponsor
- B. Braun Melsungen AG
Peripheral Arterial Disease
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.
- Trial name
- NCT04706273
- Testing
- GORE® VIABAHN® Endoprosthesis
- Where
- Japan
- Volunteers
- 321 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03174522
- Testing
- REX-001
- Where
- 15 sites in Czechia, Hungary and 4 more
- Volunteers
- 49 people
- Sponsor
- Ixaka Ltd
Diabetes Mellitus, Type 2, Diabetic Foot
Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
The goal of this clinical investigation is to explore a non-invasive technology for measuring the microcirculatory structure, composition and function in patients from a primary care population. The main aims are: 1.
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Foot, Peripheral Arterial Disease, Skin Cancer
- Trial name
- Spectrum1 (NCT06976073)
- Where
- 3 sites in Sweden
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- HJN Sverige AB/Neko Health
Critical Limb Ischemia
To Evaluate the Safety and Efficacy of IM and IV Administration of Autologous ADMSCs for Treatment of CLI
Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation.
- Trial name
- NCT02145897
- Testing
- Autologous Stromal Vascular Fraction (SVF), Autologous Adipose Derieved MSCs, Control
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Kasiak Research Pvt. Ltd.
Critical Limb Ischemia (CLI)
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or…
- Trial name
- GENIUS (NCT04849325)
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 29 sites in China
- Volunteers
- 120 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol.
- Conditions
- Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia
- Trial name
- ACTFAST 2 (NCT00442325)
- Testing
- Atorvastatin (Lipitor)
- Where
- 32 sites in Greece, Hungary and 6 more
- Volunteers
- 595 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Peripheral Arterial Occlusion or Emboli
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or…
- Trial name
- PRISM (NCT02085551)
- Testing
- Mechanical Thrombectomy by the Indigo System
- Where
- 5 sites in United States
- Volunteers
- 85 people
- Sponsor
- Penumbra Inc.
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion
Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion
- Trial name
- NCT03121430
- Testing
- Drug eluting peripheral vascular stent system, Nitinol Stent System
- Where
- China
- Volunteers
- 138 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Peripheral Arterial Disease, Claudication
Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease
The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon…
- Trial name
- DEFINITIVE AR (NCT01366482)
- Testing
- Cotavance Drug-Eluting Balloon, TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
- Where
- Belgium
- Volunteers
- 121 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease
An Evaluation of a Clinical Algorithm With Turbo-Power Following Treatment of Specific Morphologies
To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform…
- Trial name
- REX (NCT02921542)
- Testing
- Laser Atherectomy
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease, Peripheral Vascular Disease
Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the safety and activity of two doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with chronic critical limb…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00956332
- Testing
- MultiGeneAngio
- Where
- 7 sites in Israel
- Volunteers
- 28 people
- Sponsor
- MultiGene Vascular Systems Ltd.
Critical Limb Ischemia (CLI)
Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)
This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI). Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI…
- Trial name
- NCT03746899
- Testing
- PLX-PAD
- Sponsor
- WideTrial, Inc.