Clinical trials: Peripheral Artery Disease
Chronic Limb-Threatening Ischemia
Pivotal Trial of the Boomerang Catheter for pDVA
The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia.
- Trial name
- NCT06311773
- Testing
- Boomerang Catheter
- Where
- 25 sites in United States
- Volunteers
- 120 people
- Sponsor
- Aveera Medical, Inc.
Peripheral Artery Disease
Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization
To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.
- Trial name
- REVEAL (NCT02961894)
- Testing
- Revolution™ Peripheral Atherectomy System
- Where
- 17 sites in United States
- Volunteers
- 121 people
- Sponsor
- Rex Medical
Peripheral Arterial Disease
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
- Trial name
- EXCITE ISR (NCT01330628)
- Testing
- Turbo Elite Laser and Turbo Tandem Laser Guide Catheters, Balloon angioplasty
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 252 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease
Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia
Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues up to 2cm below the skin. It has been investigated, with success, in cerebral, gastrointestinal, and muscle tissue, and shows promise…
- Trial name
- NCT00224328
- Testing
- ODISsey Tissue Oximeter
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- ViOptix Canada
Aortoiliac Occlusive Disease, Peripheral Arterial Disease
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease
The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
- Trial name
- NCT05811364
- Testing
- Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
- Where
- 43 sites in United States, Australia and 5 more
- Volunteers
- 244 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease
SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral…
- Trial name
- STOP-PAD (NCT02544204)
- Testing
- JVS-100
- Where
- 24 sites in United States
- Volunteers
- 120 people
- Sponsor
- Juventas Therapeutics, Inc.
Peripheral Artery Disease, Peripheral Vascular Disease
Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia
The The purpose of this study is to determine the safety of PLX-PAD single dose, Intra-muscular injection for the treatment of CLI patients.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00919958
- Testing
- PLX-PAD IM injection
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Pluristem Ltd.
Peripheral Vascular Diseases
ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries
The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
- Trial name
- NCT00180505
- Testing
- ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent
- Where
- 13 sites in Austria, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease
Evaluate the Efficacy and Safety of the Cilostazol-coated BioMimics 3D Stent System in Patients with Peripheral Arterial Occlusive Disease
An exploratory evaluation of the efficacy and safety of CLZ-BM3D for the treatment of symptomatic peripheral occlusive arterial disease of the superficial femoral artery or proximal popliteal artery
- Trial name
- NCT05759819
- Testing
- Standard stenting
- Where
- 5 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Otsuka Medical Devices Co., Ltd. Japan
Diabetes, Peripheral Arterial Disease
DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease
This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (PAD).
- Trial name
- NCT02145988
- Testing
- DLBS1033
- Where
- 2 sites in Indonesia
- Volunteers
- 11 people
- Sponsor
- Dexa Medica Group
Intermittent Claudication
Mixed Antagonist of Serotonin for Claudication Optimal Therapy
To investigate in patients suffering from intermittent claudication due to Fontaine stage II PAD whether a 24-week treatment by SL650472 OD on top of clopidogrel may result in an improvement of walking capacity, by comparing…
- Trial name
- MASCOT (NCT00300339)
- Testing
- SL650472, Clopidogrel
- Where
- 9 sites in United States, Belgium and 7 more
- Volunteers
- 599 people
- Sponsor
- Sanofi
Peripheral Arterial Diseases
Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease
To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically…
- Trial name
- DANCE (NCT01983449)
- Testing
- Dexamethasone Sodium Phosphate Injection, USP
- Where
- 38 sites in United States
- Volunteers
- 285 people
- Sponsor
- Mercator MedSystems, Inc.
Peripheral Artery Disease, Peripheral Arterial Occlusive Disease
The EasyFlype/EasyHiFlype Post Market Clinical Follow-up Study.
The Easy Flype Carbostent™ is a CE-marked nitinol self-expanding stent for superficial femoral artery (SFA) and Easy HiFlype Carbostent™is a CE-marked nitinol self-expanding stent for iliac vessels.
- Trial name
- NCT05616169
- Testing
- Easy Flype/EasyHiFlype
- Where
- 2 sites in Italy
- Volunteers
- 52 people
- Sponsor
- CID S.p.A.
Peripheral Arterial Disease, Peripheral Arterial Disease(PAD)
Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)
The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.
- Trial name
- NCT06758921
- Testing
- Oscar Peripheral Multifunctional Catheter
- Where
- 16 sites in Austria, Belgium and 6 more
- Volunteers
- 200 people
- Sponsor
- Biotronik AG
Critical Limb Ischemia
Efficacy and Safety of Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia
This clinical trial is designed as a Phase 1/2a clinical trial targeting patients with critical limb ischemia. The trial is composed of Phase 1 to assess the tolerability and safety and Phase 2a to assess the safety and efficacy…
- Trial name
- NCT04661644
- Testing
- Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial), Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^8 cells/1 mL/vial)
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- S.Biomedics Co., Ltd.
Intermittent Claudication
Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions
The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 2-treatment…
- Trial name
- NCT00602407
- Testing
- Cilostazol
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Peripheral Arterial Disease
Chocolate Balloon Angioplasty Registry
To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the effectiveness of the device for use during percutaneous transluminal angioplasty (PTA) procedures.
- Trial name
- Chocolate BAR (NCT01589042)
- Where
- 13 sites in United States
- Volunteers
- 490 people
- Sponsor
- TriReme Medical, LLC
Peripheral Arterial Disease, Peripheral Vascular Diseases
ACHIEVE GRX Registry
This study will evaluate real-world performance of the CorPath GRX System in peripheral vascular interventions.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Renal Artery Disease, Carotid Artery Diseases
- Trial name
- NCT04513613
- Testing
- Procedure/Surgery: Robotic-PVI
- Sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
Peripheral Arterial Disease
Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access
The primary objective of this clinical investigation was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon…
- Trial name
- RADIANCY (NCT05399680)
- Testing
- S.M.A.R.T. RADIANZ™ Vascular Stent System, BRITE TIP RADIANZ™ Guiding Sheath, SABERX RADIANZ™ PTA Balloon Catheter
- Where
- 12 sites in Austria, Belgium and 4 more
- Volunteers
- 151 people
- Sponsor
- Cordis US Corp.
Peripheral Arterial Disease, Symptomatic Femoropopliteal Lesions
The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total…
- Trial name
- PTAB1 (NCT06315023)
- Testing
- DETOUR System
- Where
- 10 sites in United States
- Volunteers
- 450 people
- Sponsor
- Endologix