Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia

Critical Lower Limb Ischemia Clinical Trial

Official title:

Long Surgical Bypass Versus Hybrid Approaches for Management of Critical Limb Ischemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490408
• Other study ID #: EBRN71
• Status: Completed
• Phase: N/A
• Start date: September 20, 2014
• Est. completion date: April 17, 2019

Study information

• Verified date: July 2020
• Source: Egyptian Biomedical Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 17, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Lower Limb Ischemia
• Ischemia

Intervention

Procedure:
• long surgical bypass
long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
• Hybrid approach
Hybrid approach including bypass and endovascular revascularization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Biomedical Research Network

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late occlusion	Late occlusion of the affected vessels	2 years