At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,843 enrolled
Drug / intervention
Open surgical revascularization +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
In Brief
A clinical study evaluating Open surgical revascularization and Endovascular revascularization for Critical Limb Ischemia. Completed, enrolled 1,843 participants across 161 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia
CountriesCanada, Finland, Italy, New Zealand, United States
CollaboratorsBrigham and Women's Hospital, Massachusetts General Hospital, Boston Medical Center, National Heart, Lung, and Blood Institute (NHLBI), Abbott, Bard Ltd, Boston Scientific Corporation, Cordis US Corp., Abbott Medical Devices, Canadian Society for Vascular Surgery, Eastern Vascular Society, W.L.Gore & Associates, Midwest Vascular Society, New England Society for Vascular Surgery, Society for Clinical Vascular Surgery, Society for Interventional Radiology, Southern Vascular Society, Society for Vascular Medicine, Society for Vascular Surgery, Vascular and Endovascular Surgery Society, Vascular Interventional Advances, Western Vascular Society
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartAug 2014
Primary CompletionMar 2022
TodayJul 2026
First PostedFeb 12, 2014
Enrollment StartAug 1, 2014
Primary CompletionMar 1, 2022
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 12.4 years ago
Interventions
Open surgical revascularizationprocedure
Endovascular revascularizationdevice
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.