Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia

Egyptian Biomedical Research Network

Status: Completed

Conditions: Critical Lower Limb Ischemia

Treatments: Procedure: Hybrid approach; Procedure: long surgical bypass

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04490408

EBRN71

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

long surgical bypass

Active Comparator group

Description:

long surgical bypass for multilevel lower limb ischemia

Treatment:

Procedure: long surgical bypass

Hybrid approach

Experimental group

Description:

surgical bypass and endovascular treatment for multilevel lower limb ischemia

Treatment:

Procedure: Hybrid approach