Clinical trials: Peripheral Vascular Disease
Peripheral Artery Disease, De Novo Stenosis
Compare the Effectiveness and Safety of Genoss® DCB and IN.PACT Admiral® DCB in Patients With Peripheral Artery Disease
The purpose of this clinical trial is to demonstrate the non-inferiority of GENOSS DCB versus IN.PACT Admiral DCB on late lumen loss 6 months after the procedure in patients with de novo or non-stented restenotic lesions of the…
- Trial name
- NCT05134545
- Testing
- Genoss® DCB, IN.PACT Admiral® DCB
- Where
- South Korea
- Volunteers
- 119 people
- Sponsor
- Genoss Co., Ltd.
Iliac Artery Stenosis
EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.
- Trial name
- ORION (NCT00896337)
- Testing
- Epic™ Nitinol Stent System, Anti-platelet therapy, Anti-coagulation therapy
- Where
- 28 sites in United States
- Volunteers
- 125 people
- Sponsor
- Boston Scientific Corporation
Diabetic Foot Ulcer, Dehiscence of Amputation Stump
Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations
This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint.
- Conditions
- Diabetic Foot Ulcer, Dehiscence of Amputation Stump, Amputation
- Trial name
- Odinn (NCT04257370)
- Testing
- Kerecis™ Omega3 Wound, Standard of care
- Where
- France
- Volunteers
- 260 people
- Sponsor
- Kerecis Ltd.
Critical Limb Ischemia, Ischemia
HemaTrate™ in the Treatment of Critical Limb Ischemia
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia.
- Trial name
- NCT03809494
- Testing
- HemaTrate™ Blood Filtration system, Saline
- Where
- 3 sites in United Kingdom
- Volunteers
- 2 people
- Sponsor
- Cook Research Incorporated
Diabetic Foot, Diabetic Peripheral Neuropathy
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy
The primary aim of this study is to use the Orpyx® SI Sensory Insole System (Orpyx Medical Technologies Inc., Calgary AB, Canada) ("Orpyx" or "the Company") as an adjunct to diabetic peripheral neuropathy standard of care (SOC)…
- Trial name
- NCT05613556
- Testing
- Orpyx SI® Sensory Insole System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Orpyx Medical Technologies Inc.
Peripheral Vascular Disease
Safety and Efficacy of the URECA CTO Device
Clinical study to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the…
- Trial name
- NCT04385381
- Testing
- URECA CTO device
- Where
- Netherlands
- Volunteers
- 11 people
- Sponsor
- Ureca BV
Peripheral Vascular Disease
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is designed to assess the efficacy and safety of the…
- Trial name
- NCT00059657
- Testing
- Ecraprost in lipid emulsion
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 280 people
- Sponsor
- Tanabe Pharma Corporation
Peripheral Vascular Diseases, Intermittent Claudication
Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease (Intermittent Claudication)
Patients with peripheral artery disease have decreased blood flow to exercising muscle causing pain. This decreased blood flow to the muscle affects the level of acylcarnitines which in turn decreases the level of carnitine.
- Trial name
- NCT00399919
- Testing
- Propionyl-L-Carnitine, PLC
- Where
- 9 sites in United States
- Volunteers
- 69 people
- Sponsor
- Sigma-Tau Research, Inc.
Popliteal Artery Disease, Superficial Femoral Artery Disease
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Percutaneous Transluminal Angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries.
- Trial name
- MAGICAL SFA (NCT07359807)
- Testing
- Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter, Paclitaxel drug-coated balloon angioplasty
- Volunteers
- 478 people
- Sponsor
- Concept Medical Inc.
Intermittent Claudication
Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions
The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment…
- Trial name
- NCT00602173
- Testing
- Cilostazol
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Peripheral Arterial Disease (PAD)
Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long history of use in medical devices.
- Trial name
- NCT00196066
- Testing
- Peripheral Vessel Stenting
- Volunteers
- 150 people
- Sponsor
- Cook Group Incorporated
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Angiopathy, Peripheral
- Trial name
- SIGNATURE (NCT04971772)
- Where
- 11 sites in Brazil, Germany and 1 more
- Volunteers
- 150 people
- Sponsor
- Cardionovum GmbH
Peripheral Arterial Disease, Peripheral Vascular Disease
Clinical Pilot-Study of ProEndoTecc Vascular Grafts as Superficial Femoral Artery Bypass / Interponate
This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as superficial femoral artery bypass/interponate.
- Trial name
- NCT01095237
- Testing
- ProEndoTecc Vascular Graft
- Where
- 12 sites in Germany
- Volunteers
- 33 people
- Sponsor
- NonWoTecc Medical GmbH
Peripheral Artery Disease
A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.
- Trial name
- NCT05415995
- Testing
- Drug eluting Balloon
- Where
- 20 sites in China
- Volunteers
- 202 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Peripheral Arterial Vascular Disease
Open Label Clinical Study to Assess the Clinical Safety of a New Compression Device in Subjects With Peripheral Arterial Vascular Disease
To assess the safety of a new compression device applied to patients with an ankle brachial pressure index (ABPI) 0,5 - 0,8 who are treated for two weeks in daily routine practice.
- Trial name
- NCT00854516
- Testing
- A new treatment approach is to have an effective working pressure combined with a low resting pressure.
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Solventum US LLC
Arterial Occlusive Disease, Ulcers
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
The purpose of this study is to evaluate whether intramuscular injections of NL003 into the calf is safe and effective in the treatment of critical limb ischemia
- Conditions
- Arterial Occlusive Disease, Ulcers, Ischemia, Peripheral Vascular Disease
- Trial name
- NL003CLI-II (NCT01548378)
- Testing
- NL003, Normal Saline
- Where
- 9 sites in China
- Volunteers
- 200 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
PAD - Peripheral Arterial Disease
Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) After Sub-optimal Percutaneous Transluminal Angioplasty (PTA) or Atherectomy: REACTIVATE I
Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) after Sub-optimal percutaneous transluminal angioplasty…
- Trial name
- REACTIVATE I (NCT05455021)
- Testing
- Vessel Restoration System (VRS)
- Where
- 2 sites in Australia
- Volunteers
- 50 people
- Sponsor
- Alucent Biomedical
Peripheral Artery Disease
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).
- Trial name
- SUCCESS PTA (NCT04776434)
- Testing
- SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)
- Where
- 27 sites in Argentina, Germany and 6 more
- Volunteers
- 723 people
- Sponsor
- M.A. Med Alliance S.A.
Peripheral Arterial Disease, Intermittent Claudication
Utility, Safety, and Effectiveness of the Bard LifeStent 5F Vascular Stent System
The medical device being examined in this study is the Bard® LifeStent® 5F Vascular Stent System. It is intended for use in patients who suffer from peripheral artery disease (PAD).
- Trial name
- REALITY III (NCT03071146)
- Testing
- Bard® LifeStent® 5F Vascular Stent System
- Where
- 4 sites in Germany
- Volunteers
- 30 people
- Sponsor
- C. R. Bard
Foot Ulcer, Diabetic Foot
A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX
The purpose of this study is to evaluate the efficacy and safety of REGRANEX® Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes.
- Conditions
- Foot Ulcer, Diabetic Foot, Skin Ulcer, Diabetic Neuropathies
- Trial name
- NCT00034788
- Testing
- Becaplermin
- Volunteers
- 84 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.