Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia

Not Applicable

Completed

• Conditions: Critical Lower Limb Ischemia
• Interventions: Procedure: Hybrid approach; Procedure: long surgical bypass

• Registration Number: NCT04490408
• Lead Sponsor: Egyptian Biomedical Research Network

Brief Summary

The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-20
• Primary Completion: 2019-04-17
• Study Completion: 2019-04-17
• Status Verified: 2020-07
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Last Update Submitted: 2020-07-24
• Study First Posted: 2020-07-29
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• TASC II type D femoropopliteal lesions with intact ipsilateral femoral pulse.
• Fontaine classification stage IV (gangrene or necrosis).
• Rutherford grade III and IV category 5 and 6 with salvageable foot

Exclusion Criteria

• heart failure
• liver failure
• renal impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid approach	Hybrid approach	surgical bypass and endovascular treatment for multilevel lower limb ischemia
long surgical bypass	long surgical bypass	long surgical bypass for multilevel lower limb ischemia

Primary Outcome Measures

Name	Time	Method
Late occlusion	2 years	Late occlusion of the affected vessels