Clinical trials: Critical Ischemia Limb
Arterial Occlusive Diseases
Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)
Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized…
- Trial name
- NCT00282646
- Testing
- intraarterial stem cell therapy, Stem cells
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
Peripheral Arterial Disease, Claudication
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
- Conditions
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT00883246
- Testing
- SilverHawk & TurboHawk Peripheral Plaque Excision System
- Volunteers
- 800 people
- Sponsor
- Medtronic Endovascular
Critical Limb Ischemia
Serrantor OCT Study
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
- Trial name
- NCT06434194
- Testing
- Serranator PTA Serration Catheter, PTA (Standard of Care)
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cagent Vascular LLC
Critical Limb Ischemia
Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia
Background: Up to 10% of patients with peripheral arterial disease (PAD) will develop critical limb ischemia (CLI) which is a decrease of blood flow in the arteries of the limb.
- Trial name
- RIVAL-PAD (NCT02260622)
- Testing
- rivaroxaban plus aspirin, clopidogrel plus aspirin
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Ottawa Hospital Research Institute
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.
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.
Critical Limb Ischemia
A Retrospective Analysis of Patients With Full Thickness Wounds in Limbs With Critical Ischemia
Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated.
- Trial name
- NCT00760357
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Southwest Regional Wound Care Center
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
Peripheral Arterial Occlusive Disease
EXCimEr Laser for Long lENgTh Lesions in Below-The-Knee Arteries Study
This investigation is designed to assess the immediate and long-term angiographic patency outcomes of excimer laser recanalisation followed by PTA in the treatment of long (>50 mm) infrapopliteal lesions in patients with critical…
- Trial name
- EXCELLENT-BTK (NCT00718991)
- Testing
- Spectranetics Turbo elite™ excimer laser catheter
- Where
- 2 sites in Belgium
- Volunteers
- 14 people
- Sponsor
- Flanders Medical Research Program
Peripheral Vascular Disease
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.
- Trial name
- NCT00300040
- Testing
- Hemoglobin glutamer 250 - bovine, 6% Hydroxyethylstarch
- Where
- 5 sites in South Africa, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Biopure Corporation
Peripheral Arterial Disease, Critical Limb Ischemia
Swedish Drug-elution Trial in Peripheral Arterial Disease
Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries.
- Conditions
- Peripheral Arterial Disease, Critical Limb Ischemia, Intermittent Claudication
- Trial name
- SWEDEPAD (NCT02051088)
- Testing
- Revascularization with drug-eluting technology, Revascularization without drug-eluting technology, drug-coated balloons and/or drug-eluting stents
- Where
- Sweden
- Volunteers
- 3,556 people
- Sponsor
- Sahlgrenska University Hospital
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
Spectroscopic Assessment of Tissue Oxygenation Changes During Vascular Surgery
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.
- Conditions
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia Vascular, Tissue Ischemia
- Trial name
- NCT07786623
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Chronic Limb-Threatening Ischemia
Agreement Study on AI-assisted Smartphone-based Monitoring Tool for Difficult-to-heal Ischemic Leg Ulcers
The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with…
- Trial name
- NCT06421961
- Where
- Sweden
- Volunteers
- 223 people
- Sponsor
- Sahlgrenska University Hospital
Critical Limb Ischemia
Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)
Prospective, randomized, controlled, multi-center study A total of 390 subjects with critical limb ischemia will be included according to inclusion and exclusion criteria.
- Trial name
- NCT02829151
- Testing
- Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) ), Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel, Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol
- Where
- South Korea
- Volunteers
- 390 people
- Sponsor
- Yonsei University
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice.
- Trial name
- ORACLE (NCT07270562)
- Testing
- Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
- Where
- United Kingdom
- Volunteers
- 250 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Peripheral Arterial Disease, Angioplasty
Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS Trial
The PACUS Trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to improve local Paclitaxel delivery effects in…
- Trial name
- PACUS (NCT02625740)
- Testing
- Local exposition of target lesion to high intensity, low-frequency ultrasound, drug eluting ballon angioplasty, Flow occlusion with an angioplasty balloon
- Volunteers
- 56 people
- Sponsor
- University of Rome Tor Vergata
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
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
Evaluation of Tissue Perfusion in Peripheral Arterial Disease (EVTI-PAD)
In this prospective single-center observational study, arterial perfusion in patients with lower limb peripheral arterial disease will be assessed with standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure…
- Conditions
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Critical Limb Ischemia
- Trial name
- EVTI-PAD (NCT05570019)
- Testing
- Revascularization
- Where
- Austria
- Volunteers
- 200 people
- Sponsor
- Medical University Innsbruck
Chronic Limb Threatening Ischemia
Multimodal Noninvasive Assessment of Peripheral Circulation in Chronic Limb-threatening Ischemia
Assessment of a novel diagnostic method for screening and diagnosing chronic limb-threatening ischemia (CLTI). Using hyperspectral and thermal imaging, the perfusion and oxygenation in the lower limbs will be studied in healthy…
- Trial name
- NCT05786001
- Where
- Finland
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Tampere University
Peripheral Artery Disease
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia
Non-randomized, multi-center, longitudinal study of healthy subjects and subjects with PAD who are scheduled for ABI, TBI, and either Duplex Ultrasound or Angiographic assessments in a vascular clinic.
- Trial name
- NCT04120610
- Testing
- FlowMet-R, ABI, TBI
- Where
- 5 sites in United States
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- Medtronic Endovascular