Clinical trials: Chronic Limb-threatening Ischemia
Critical Limb Ischemia
Continuous Sciatic Block Nerve in the Management of Vascular Pain in Critical Ischemia of Lower Limbs Patients
Critical limb ischemia (CLI) is associated with severe pain that is a therapeutic challenge whit therapeutic limits for the use of conventional analgesics medications.
- Trial name
- NCT04278014
- Testing
- ultrasound-guided continuous sciatic block with longitudinal approach
- Where
- 2 sites in Colombia
- Volunteers
- 13 people
- Sponsor
- Universidad de Antioquia
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
Peripheral Arterial Disease
ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment of lesions in "below the…
- Trial name
- BTK PMS (NCT03395236)
- Testing
- StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon
- Where
- 10 sites in Germany, Netherlands and 1 more
- Volunteers
- 49 people
- Sponsor
- Spectranetics Corporation
Critical Limb Ischemia
Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia
Percutaneous transluminal angioplasty (PTA) of infra-popliteal arteries in patients suffering peripheral arterial occlusive disease (PAOD) provides good results in terms of limb salvage.
- Trial name
- NCT02498080
- Testing
- DEB PTA, Standard PTA
- Volunteers
- 60 people
- Sponsor
- Neuromed IRCCS
Critical Limb Ischemia
Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study
Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity.
- Trial name
- STT-CLIPS (NCT02091921)
- Testing
- Ticagrelor
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Critical Limb Ischemia
SCOPE CLI (Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia)
Given the importance of understanding CLI patients' outcomes and existing gaps in knowledge, there is a pressing need to collect observational data on treatment patterns, adherence to performance measures, and outcomes that are…
- Trial name
- SCOPE CLI (NCT03171259)
- Testing
- care as usual
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Saint Luke's Health System
Critical Limb Ischemia
Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia
Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.
- Trial name
- AGILITY (NCT02144610)
- Testing
- HGF Plasmid (AMG0001)
- Where
- 60 sites in United States, Belgium and 9 more
- Volunteers
- 46 people
- Sponsor
- AnGes USA, Inc.
Vascular Diseases
Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex
Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.
- Trial name
- NCT05296031
- Testing
- Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions, Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
- Volunteers
- 49 people
- Sponsor
- Skane University Hospital
Vascular Diseases, Diabetes
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II)
The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts.
- Trial name
- DCLI-II (NCT01173094)
- Testing
- Percutaneous Transluminal Angioplasty, below-knee arterial bypass
- Where
- 3 sites in China
- Volunteers
- 130 people
- Sponsor
- Peking Union Medical College Hospital
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.
Critical Limb Ischemia, Peripheral Arterial Disease
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLIC (NCT02145845)
- Testing
- Injectable SIS
- Where
- Czechia
- Volunteers
- 13 people
- Sponsor
- Cook Group Incorporated
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.
Femoropopliteal Disease, Drug Coated Balloon
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel…
- Conditions
- Femoropopliteal Disease, Drug Coated Balloon, Critical Limb-Threatening Ischaemia, Peripheral Arterial Disease
- Trial name
- DASBAD-NC (NCT07764016)
- Testing
- Non-compliant Plain Balloon angioplasty (PBA), Non-compliant Scoring Balloon Angioplasty (SB)
- Volunteers
- 142 people
- Sponsor
- Marc Sirvent
Chronic Limb-threatening Ischemia, Diabetes Mellitus
Bone Marrow Mononuclear Cells vs Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb Ischemia
Patients in the severe stages of Chronic limb-threatening ischemia (CLTI) are prone to amputation and death, leading to poor quality of life and a great socioeconomic burden.
- Trial name
- NCT05631444
- Testing
- Cell-based therapy
- Where
- Colombia
- Volunteers
- 24 people
- Sponsor
- Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Critical Limb Ischemia (CLI)
Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)
This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI). Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI…
- Trial name
- NCT03746899
- Testing
- PLX-PAD
- Sponsor
- WideTrial, Inc.
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
SELUTION4BTK Trial
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in…
- Trial name
- NCT05055297
- Testing
- SELUTION SLR™ DEB 014, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 48 sites in United States, Austria and 8 more
- Volunteers
- 376 people
- Sponsor
- M.A. Med Alliance S.A.
Critical Limb Ischemia
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
- Trial name
- ILLUMENATE-BTK (NCT03175744)
- Testing
- Stellarex DCB, PTA Catheter
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 82 people
- Sponsor
- Spectranetics Corporation
Critical Limb Ischemia
Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
Using gene therapy to express active telomerase (hTERT) in human cells has the potential to treat many diseases related to aging, including critical limb ischemia (CLI).
- Trial name
- NCT04110964
- Testing
- AAV-hTERT
- Where
- Colombia
- Volunteers
- 5 people
- Sponsor
- Libella Gene Therapeutics
Chronic Limb-Threatening Ischemia
Validating GLASS Score in Predicting Acute Limb Events in CLTI Patients
Ischemia is a severe medical condition that occurs when the blood and oxygen supply to a specific part of the body is significantly reduced or completely absent, it can affect any body part, often the legs.
- Trial name
- PROMOTEGLASS (NCT06186544)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Cardiff and Vale University Health Board
Critical Limb Ischemia (CLI)
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or…
- Trial name
- GENIUS (NCT04849325)
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 29 sites in China
- Volunteers
- 120 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.