Clinical trials: Limb Ischemia
Critical Limb Ischemia, Peripheral Artery Disease
Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair
The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the…
- Trial name
- NCT02044003
- Testing
- Innovasc Tack Intravascular Staple System (Tack)
- Where
- 2 sites in Paraguay
- Volunteers
- 11 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Lower Extremity Acute Limb Ischemia, LE ALI
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
- Trial name
- STRIDE (NCT04144959)
- Testing
- Indigo Aspiration System
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 119 people
- Sponsor
- Penumbra Inc.
Critical Limb Ischemia
A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia
This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.
- Trial name
- NCT02477540
- Testing
- Cellgram-CLI
- Sponsor
- Pharmicell Co., Ltd.
Critical Limb Ischemia
Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores…
- Trial name
- NCT01245335
- Testing
- BMAC injection
- Where
- 34 sites in United States
- Volunteers
- 97 people
- Sponsor
- Harvest Technologies
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Critical Limb Ischemia
Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease
Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in treating 18 recipients with ischemic limb…
- Trial name
- NCT02336646
- Testing
- Allogenic MSC, Normal saline
- Where
- Taiwan
- Volunteers
- 18 people
- Sponsor
- Taiwan Bio Therapeutics Inc.
Atherosclerosis
Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid
In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways.
- Trial name
- XATOA (NCT03746275)
- Testing
- Rivaroxaban (BAY59-7939, Xarelto), Acetylsalicylic acid
- Where
- 18 sites in Argentina, Brazil and 16 more
- Volunteers
- 5,798 people
- Sponsor
- Bayer
Critical Limb Ischemia
Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia
The purpose of this study is to evaluate the safety and efficacy of the concentrated autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia patients.
- Trial name
- NCT01472289
- Testing
- Autologous Bone Marrow Mononuclear cells (BMMNCs)
- Where
- India
- Volunteers
- 17 people
- Sponsor
- TotipotentSC Scientific Product Pvt. Ltd.
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
Cardiac Surgery, Ischemia Limb
Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach
This is a first-in-human, prospective, single-arm, phase I clinical study evaluating the safety of the iPerf femoral arterial cannula in patients undergoing planned cardiac surgery requiring extracorporeal circulation (ECC) via a…
- Trial name
- FIH IPERF-01 (NCT07163234)
- Testing
- Cardiac surgery
- Where
- 2 sites in France
- Volunteers
- 15 people
- Sponsor
- IPERF SAS
Chronic Limb-Threatening Ischemia
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions.
- Trial name
- ELITE-BTK (NCT06071429)
- Testing
- MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA)
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- R3 Vascular Inc.
Ischemic Stroke, Upper Extremity Paresis
A Trial of Rehabilitation Paired With VNS for Motor Function in Patients With Stroke (Repair Study)
The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) paired with rehabilitation for enhancing upper extremity motor function after ischemic stroke.
- Trial name
- NCT06722677
- Testing
- VNS, Rehabilitation
- Where
- 13 sites in China
- Volunteers
- 99 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Chronic Limb Ischemia, Non-Healing Ulcers
Hyperspectral Imaging Pre and Post Endovascular Intervention
This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.
- Trial name
- CLI-Pre/Post (NCT00768495)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- HyperMed
Peripheral Artery Disease, Peripheral Vascular Disease
Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)
The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00951210
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Pluristem Ltd.
Peripheral Arterial Disease
A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD
The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD).
- Trial name
- Concerto (NCT05100745)
- Testing
- Therapeutic Device
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Vibrato Medical, Inc.
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
Peripheral Artery Disease, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Secondary Stroke
A Study to Evaluate Cenvacibart (REGN7508) for Secondary Stroke Prevention in Adult Participants
This study will test an experimental Regeneron drug called cenvacibart (REGN7508) ("study drug") compared with a placebo (a look-alike treatment with no active medicine) on top of background antiplatelet medications.
- Trial name
- ROXI-DAISEN (NCT07876492)
- Testing
- Cenvacibart
- Volunteers
- 6,106 people
- Sponsor
- Regeneron Pharmaceuticals
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 Arterial Disease
Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)
This study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (PAD) patients 65 years of age and over.
- Trial name
- Waltz (NCT05888740)
- Testing
- VibratoSleeve Therapeutic Ultrasound Device
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Vibrato Medical, Inc.