Clinical trials: Chronic Limb-threatening Ischemia
Peripheral Artery Disease, Vascular Disease
Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging
This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an endovascular intervention of the…
- Conditions
- Peripheral Artery Disease, Vascular Disease, Critical Limb Ischemia
- Trial name
- INVADER_MRI (NCT02807779)
- Testing
- Dexamethasone infusion, Drug coated balloon, Plain balloon angioplasty
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of California, San Francisco
Peripheral Vascular Diseases
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
- Trial name
- PROOF (NCT00504088)
- Testing
- Bypass, Silverhawk Plaque Excision
- Where
- 31 sites in United States
- Sponsor
- FoxHollow Technologies
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Critical Limb Ischemia, Severe Leg Ischemia
Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of…
- Conditions
- Critical Limb Ischemia, Severe Leg Ischemia, Peripheral Artery Disease, Peripheral Vascular Disease
- Trial name
- MESENDO (NCT00721006)
- Testing
- MESENDO
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- TCA Cellular Therapy
Critical Limb Ischemia
Investigating the Safety and Efficacy of the Treatment With Luminor DCB and Angiolite DES of iVascular in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia
This study aims to evaluate the 12 month outcome of the mono- or combination therapy with iVascular Luminor DCB and Angiolite DES for treatment of TASC C and TASC D long tibial occlusive disease, presenting with critical limb…
- Trial name
- MERLION (NCT04073121)
- Testing
- Luminor DCB and Angiolite DES
- Where
- 2 sites in Singapore
- Volunteers
- 50 people
- Sponsor
- Singapore General Hospital
Critical Limb Ischemia
Scandinavian Miller Collar Study
Randomized study to evaluate the effect of adding a vein collar at the distal anastomosis to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary…
- Trial name
- SCAMICOS (NCT01285986)
- Testing
- Vein collar at the distal anastomosis
- Where
- Sweden
- Volunteers
- 352 people
- Sponsor
- University Hospital, Linkoeping
Chronic Critical Limb Ischemia, Peripheral Vascular Diseases
Study to Evaluate the Safety & Performance of the Xpert(TM) Stent in Treating Below-the-knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic CLI.
The purpose of this study is to evaluate the safety and performance of the Xpert(TM) self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in patients undergoing percutaneous intervention for the…
- Trial name
- XCELL (NCT00515346)
- Testing
- Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- VIVA Physicians
PAD, Infrapopliteal Lesions
European Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)
To evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the Cotavance Paclitaxel-Coated…
- Trial name
- NCT01260870
- Testing
- Cotavance Paclitaxel Coated Balloon, Standard balloon angioplasty
- Where
- 6 sites in Austria, Belgium and 2 more
- Volunteers
- 44 people
- Sponsor
- Bayer
Peripheral Arterial Disease, Arterial Occlusive Diseases
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery
The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
- Conditions
- Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis
- Trial name
- PAVENST (NCT02212470)
- Testing
- Drug Eluting Balloon Angioplasty, Nitinol stenting
- Where
- Brazil
- Volunteers
- 85 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
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
Critical Limb Ischemia
Swedish External Support Study
Randomized study to evaluate the effect of adding external support to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage.
- Trial name
- SWEXSUS (NCT01273740)
- Testing
- External support
- Volunteers
- 334 people
- Sponsor
- University Hospital, Linkoeping
Femoral Arterial Calcification, Peripheral Arterial Disease
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of…
- Conditions
- Femoral Arterial Calcification, Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT05145478
- Testing
- Shockwave Intravascular Lithotripsy (IVL)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Yale University
Peripheral Artery Disease Without Critical Limb Ischemia
Non-Healing Ulcers Without Critical Limb Ischemia
Background: Lower limb arterial revascularization procedures, either percutaneously or surgically performed, are an established treatment modality of ischemic foot ulcers, especially in the setting of a critical limb ischemia.
- Trial name
- NEWLI (NCT01666093)
- Testing
- Angioplasty of the lower limbs vessels
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- University Hospital, Geneva
Peripheral Arterial Disease
SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs
A research project capturing experiences of patients with critical limb threatening ischemia, with the ultimate goal of setting new standards for diagnosing, describing detailed patient-centered outcomes, and evaluating the…
- Trial name
- SCOPE-CLI (NCT04710563)
- Where
- United States
- Volunteers
- 458 people
- Sponsor
- Yale University
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase…
- Conditions
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans
- Trial name
- NCT07023965
- Testing
- NL003
- Where
- 5 sites in China
- Volunteers
- 542 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Critical Limb Ischemia
Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.
Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups controlled by two levels of dose to assess the safety and feasibility of the infusion of mesenchymal stem cells from adipose tissue…
- Trial name
- NCT01745744
- Testing
- Mesenchymal stem cells from adipose tissue
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Ischemia Lesions
Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE
Open repair could be recommended in a first line of treatment to revascularize critical limb ischemia patients or performed in a second line of treatment in case of failure of endovascular repair.
- Trial name
- REPLACE (NCT03430076)
- Testing
- revascularization, Propaten®, Crude PTFE
- Where
- 21 sites in France
- Volunteers
- 228 people
- Sponsor
- Nantes University Hospital
Vascular Diseases, Peripheral Artery Disease
RECCORD (Recording Courses of Vascular Diseases) Registry
The RECording COurses of vasculaR Diseases registry (RECCORD registry) is an observational, prospective, multicentre, all-comers registry platform.
- Conditions
- Vascular Diseases, Peripheral Artery Disease, Claudication, Critical Limb Ischemia
- Trial name
- RECCORD (NCT03448029)
- Where
- Germany
- Volunteers
- 6,000 people
- Sponsor
- Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
Microbial Colonization, Coronary Artery Disease
Effect of Acute Cardiovascular Disease on Microbiome
Atherosclerotic diseases such as coronary artery disease (CAD) and peripheral arterial disease (PAD) are the leading cause of morbidity and mortality in the industrialized world.
- Conditions
- Microbial Colonization, Coronary Artery Disease, Myocardial Infarction, Acute Coronary Syndrome
- Trial name
- MIAMI (NCT05456802)
- Testing
- Standard of care treatment
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital, Essen
Peripheral Vascular Diseases
Bone Marrow Autograft in Limb Ischemia
BALI (Bone marrow Autograft in Limb Ischemia) is a randomized double-blind trial comparing implantation of bone marrow - mononuclear cells versus placebo in patients presenting with critical leg ischemia and no surgical option.
- Trial name
- BALI (NCT00904501)
- Testing
- Bone marrow harvest
- Where
- 15 sites in France
- Volunteers
- 40 people
- Sponsor
- CHU de Reims