Clinical trials: Peripheral Artery Diseases
Peripheral Artery Disease
Acotec DCB Post Market Clinical Follow-up
All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical…
- Trial name
- FLOWER (NCT04393389)
- Testing
- AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.
- Where
- 7 sites in Germany
- Volunteers
- 3,000 people
- Sponsor
- Acotec Scientific Co., Ltd
Peripheral Artery Disease, Peripheral Artery Stenosis
The THOR IDE Study
The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).
- Conditions
- Peripheral Artery Disease, Peripheral Artery Stenosis, Peripheral Artery Calcification, PAD
- Trial name
- THOR (NCT05916950)
- Testing
- Thor laser atherectomy
- Where
- 29 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Peripheral Arterial Disease
DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
- Trial name
- DETOUR1 (NCT02471638)
- Testing
- PQ Bypass System for Femoropopliteal Bypass
- Where
- 8 sites in Chile, Germany and 4 more
- Volunteers
- 78 people
- Sponsor
- Endologix
Peripheral Arterial Disease, Lower Extremity Arterial Disease
EverFlex Post Approval Study
This 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…
- Trial name
- DURABILITY PAS (NCT01680835)
- Testing
- EverFlex™ Self-Expanding Peripheral Stent System
- Where
- 23 sites in United States
- Volunteers
- 108 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease
Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in treatment of moderate to severely calcified…
- Trial name
- NCT00733135
- Testing
- SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device
- Volunteers
- 133 people
- Sponsor
- Medtronic Endovascular
Peripheral Artery Disease
Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis
A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis
- Trial name
- NCT04982367
- Testing
- Sirolimus-eluting balloon catheter, Paclitaxel-eluting balloon catheter
- Where
- China
- Volunteers
- 166 people
- Sponsor
- Acotec Scientific Co., Ltd
Aneurysm Abdominal, Peripheral Aneurysms
A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery…
- Conditions
- Aneurysm Abdominal, Peripheral Aneurysms, Arterial Disease Occlusive, Prothesis
- Trial name
- NCT05519826
- Testing
- Vascular surgery
- Where
- France
- Volunteers
- 373 people
- Sponsor
- Perouse Medical
Peripheral Artery Occlusive Disease
Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study
A prospective, single arm, non-randomized early feasibility study to evaluate the preliminary safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective…
- Trial name
- NCT06951685
- Testing
- Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit
- Where
- Costa Rica
- Volunteers
- 6 people
- Sponsor
- Xeltis
Cardiovascular Diseases, Smoking
Effect of Switching From Cigarette Smoking to THS on Systemic Endothelial Function in Subjects With Established Atherosclerotic Disease
The purpose of this study is to demonstrate improvement in flow mediated dilation (FMD), a functional endpoint associated with the progression of atherosclerosis, when switching from cigarettes to the Tobacco Heating System (THS)…
- Conditions
- Cardiovascular Diseases, Smoking, Tobacco Use, Peripheral Arterial Disease
- Trial name
- NCT05566678
- Testing
- Cigarette, THS, Smoking Abstinence
- Sponsor
- Philip Morris Products S.A.
Peripheral Artery Disease
Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging
A non inferiority trial to determine the capability of optical coherence tomography (OCT) imaging to show vessel morphology in comparison to imaging provided by intravascular ultrasound imaging (IVUS).
- Trial name
- SCAN (NCT03480685)
- Testing
- IVUS and OCT Imaging
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Avinger, Inc.
Diabetic Foot Ulcer, Peripheral Arterial Disease
A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
- Conditions
- Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
- Trial name
- Dulcet (NCT05145439)
- Testing
- VibratoSleeve Therapeutic Ultrasound Device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Vibrato Medical, Inc.
Peripheral Vascular Diseases
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.
- Trial name
- VIPER (NCT00541307)
- Testing
- Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Where
- 5 sites in United States
- Volunteers
- 119 people
- Sponsor
- W.L.Gore & Associates
PAD - Peripheral Arterial Disease
Feasibility Study of the Vessel Restoration System (VRS): ACTIVATE II
Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA): ACTIVATE II
- Trial name
- ACTIVATEII (NCT05454995)
- Testing
- Vessel Restoration System (VRS)
- Where
- Australia
- Volunteers
- 50 people
- Sponsor
- Alucent Biomedical
Peripheral Arterial Disease
BioMimics 3D Stent Clinical Investigation: The Mimics Study
Primary purpose of the Mimics Study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease.
- Trial name
- Mimics (NCT02163863)
- Testing
- Femoropopliteal stenting
- Where
- Germany
- Volunteers
- 86 people
- Sponsor
- Veryan Medical Ltd.
Peripheral Vascular Disease
A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.
- Trial name
- PERFORM (NCT02418156)
- Testing
- CorMatrix ECM for Vascular Repair
- Volunteers
- 38 people
- Sponsor
- Elutia 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.
Vascular Diseases, Peripheral
FLUENCY® PLUS in the Treatment of Peripheral Artery Disease
This is a retrospective, multi-center study to assess the safety and performance by proactively reviewing pre-existing medical records and imaging of patients who had previous placement of FLUENCY® PLUS Vascular Stent Graft in…
- Trial name
- NCT04765566
- Testing
- Endovascular revascularization of peripheral arteries
- Where
- 6 sites in Germany, Poland
- Volunteers
- 146 people
- Sponsor
- C. R. Bard
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
Effectiveness and Safety Study of Peripheral Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty(PTA) Procedure
The purpose of this study is to determine whether the peripheral balloon dilatation catheter (trade name: Iris) is safe an effective in PTA procedure.
- Trial name
- NCT01849601
- Testing
- percutaneous transluminal angioplasty balloon catheter
- Where
- China
- Volunteers
- 167 people
- Sponsor
- Acotec Scientific Co., Ltd
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2
Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)
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 (NCT00442845)
- Testing
- Atorvastatin (Lipitor)
- Where
- 121 sites in Cameroon, Canada and 3 more
- Volunteers
- 2,080 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.