NCT02060630

Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia

Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,843 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
PROCEDURE	Open surgical revascularization
DEVICE	Endovascular revascularization	A variety of FDA approved devices will be used within this treatment arm. The trial will submit a proof-of-concept IDE application to the FDA to cover all devices.

Timeline

• Start date: 2014-08-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2014-02-12
• Last updated: 2023-04-11

Locations

161 sites across 5 countries: United States, Canada, Finland, Italy, New Zealand

Regulatory

• FDA-regulated device study