Critical Limb Ischemia Clinical Trial
Official title:
Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.
Male and female subjects aged 18 years or older will be randomized to receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment to primarily assess survival and major adverse limb events in the index or treated limb, and secondarily, to determine clinical and cost effectiveness outcomes after treatment. These outcomes (survival-free of major limb events and clinical, functional and cost effectiveness) will be compared within two cohorts of subjects: those with an available single-segment great saphenous vein, and those with an alternative conduit. The null hypotheses for both cohorts is that there will be no difference in MALE-free survival between best endovascular therapy and best surgical therapy. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
| Recruiting |
NCT03668353 -
Recombinant SeV-hFGF2/dF Injection for PAOD
|
Phase 1 | |
| Recruiting |
NCT04110964 -
Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
|
Phase 1 | |
| Not yet recruiting |
NCT03994666 -
Cell Therapy in Critical Limb Ischemia
|
Phase 2 | |
| Recruiting |
NCT02389023 -
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
|
N/A | |
| Not yet recruiting |
NCT02498080 -
Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia
|
N/A | |
| Completed |
NCT02539940 -
Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
|
||
| Recruiting |
NCT02239419 -
Evaluation of Carbothera in the Treatment of Foot Ulcers
|
N/A | |
| Recruiting |
NCT01938872 -
Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia
|
N/A | |
| Active, not recruiting |
NCT01211925 -
Distal Venous Arterialisation of Ischemic Limb
|
Phase 2/Phase 3 | |
| Completed |
NCT02454231 -
Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA)
|
Phase 2/Phase 3 | |
| Completed |
NCT01758874 -
Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia
|
Phase 2 | |
| Completed |
NCT02475200 -
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
|
||
| Recruiting |
NCT04583436 -
Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia
|
N/A | |
| Completed |
NCT04071782 -
Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore
|
N/A | |
| Completed |
NCT03669458 -
Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.
|
N/A | |
| Not yet recruiting |
NCT06007469 -
Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
|
||
| Recruiting |
NCT04110327 -
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
|
||
| Completed |
NCT02260622 -
Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia
|
Phase 2 | |
| Recruiting |
NCT02054416 -
External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality
|
N/A |