Clinical trials: Ischemia Limb
Critical Limb Ischemia
Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia
This is a double-blind, placebo controlled study designed to evaluate the safety and efficacy of JVS-100 given to adult subjects with critical limb ischemia (CLI).
- Trial name
- NCT01410331
- Where
- 7 sites in United States, India
- Volunteers
- 48 people
- Sponsor
- Juventas Therapeutics, Inc.
Critical Limb Ischemia
Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Critical Limb Ischemia
The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain…
- Trial name
- NCT06359912
- Testing
- EPCs, Clinical standard treatment (CST)
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Allife Medical Science and Technology Co., Ltd.
Peripheral Vascular Diseases
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes…
- Trial name
- TAMARIS (NCT00566657)
- Testing
- riferminogene pecaplasmid
- Where
- 32 sites in United States, Argentina and 30 more
- Volunteers
- 525 people
- Sponsor
- Sanofi
Peripheral Arterial Disease, Acute Limb Ischemia
Pounce™ Thrombectomy System Retrospective Registry
The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.
- Trial name
- PROWL (NCT05868161)
- Testing
- Pounce Thrombectomy System
- Where
- 9 sites in United States
- Volunteers
- 500 people
- Sponsor
- SurModics, Inc.
Peripheral Vascular Diseases
Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia
The purpose of this study is to assess the safety and the immediate effect of the VascuActive device on patients with peripheral vascular disease and limb ischemia.
- Trial name
- NCT01014377
- Testing
- VascuActive
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- VascuActive LTD
Critical Limb Ischemia, Buerger's Disease
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to Buerger's…
- Trial name
- NCT05854615
- Testing
- Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells
- Where
- Malaysia
- Volunteers
- 3 people
- Sponsor
- Cell Biopeutics Resources Sdn Bhd
Critical Limb Ischemia, Peripheral Arterial Disease
ALD-301 for Critical Limb Ischemia, Randomized Trial
This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLI-001 (NCT00392509)
- Testing
- ALDH-br bone marrow cells vs. mononuclear bone marrow cells
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Aldagen
Chronic Limb-Threatening Ischemia
Esprit BTK Post-Approval Study
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients…
- Trial name
- EspritBTKPAS (NCT06656364)
- Testing
- Esprit BTK System
- Where
- 39 sites in United States, Hong Kong and 2 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for…
- Trial name
- NCT02099500
- Testing
- Liposuction, Stem Cell Injection
- Where
- United States
- Sponsor
- Ageless Regenerative Institute
Arterial Occlusive Diseases
Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI
The purpose of this study is to determine if concentrated nucleated cells from your own bone marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to avoid amputation.
- Trial name
- NCT00595257
- Testing
- centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Harvest Technologies
Critical Limb Ischemia (CLI)
Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects…
- Trial name
- NCT03006770
- Testing
- PLX-PAD
- Where
- 57 sites in United States, Bulgaria and 7 more
- Volunteers
- 213 people
- Sponsor
- Pluristem Ltd.
Critical Limb Ischemia
Mesenchymal Stem Cells in Critical Limb Ischemia
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.
- Trial name
- NCT00883870
- Testing
- mesenchymal stem cells, Plasmalyte A
- Where
- 4 sites in India
- Volunteers
- 20 people
- Sponsor
- Stempeutics Research Pvt Ltd
Peripheral Arterial Disease, Critical Limb Ischemia
Serranator Recoil Study
The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as…
- Trial name
- NCT05161039
- Testing
- Serranator, POBA
- Where
- 2 sites in United States, Germany
- Volunteers
- 20 people
- Sponsor
- Cagent Vascular LLC
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
Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.
To evaluate the safety and effectiveness of the Spur System in a patient population with infrapopliteal artery disease (tibioperoneal, anterior/posterior tibial and peritoneal arteries) when used in conjunction with…
- Trial name
- DEEPER (NCT03669458)
- Testing
- Below the Knee peripheral intervention
- Where
- Dominican Republic
- Volunteers
- 21 people
- Sponsor
- ReFlow Medical, Inc.
Peripheral Arterial Disease
Investigation of Safety, Pharmacokinetics and Pharmacodynamics of Different Doses of BIWH 3 in Patients With Chronic Critical Limb Ischaemia
The primary aim of this trial was to investigate the safety of a 6 hour intraarterial infusion of BIWH 3 (pyro-Glu-rhMCP-1) in patients with severe peripheral arterial occlusive disease (PAOD) and chronic Critical Limb Ischaemia…
- Trial name
- COINART-1 (NCT02215824)
- Testing
- BIWH 3
- Volunteers
- 7 people
- Sponsor
- Boehringer Ingelheim
Peripheral Arterial Disease, Critical Lower Limb Ischemia
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
- Trial name
- HEAL (NCT04110327)
- Testing
- MicroStent
- Where
- 10 sites in Austria, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Micro Medical Solution, Inc.
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
Patients With Symptomatic Critical Limb Ischemia, Severe Intermittent Claudication
Self Expanding Nitinol Stent Versus Percutaneous Transluminal Arterial Angioplasty (PTA) With Optional Bailout Stenting in Case of PTA Failure in Patients With Symptomatic Critical Limb Ischemia or Severe Intermittent Claudication (EXPAND)
The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow up investigations at 1, 3, 6 and 12 months.
- Trial name
- EXPAND (NCT00906022)
- Testing
- Astron Pulsar Stent, PTA alone
- Where
- Germany
- Volunteers
- 94 people
- Sponsor
- Biotronik AG
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.