Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia

July 24, 2020 updated by: Egyptian Biomedical Research Network

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: long surgical bypass
long surgical bypass for multilevel lower limb ischemia
Procedure: long surgical bypass
long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
Experimental: Hybrid approach
surgical bypass and endovascular treatment for multilevel lower limb ischemia
Procedure: Hybrid approach
Hybrid approach including bypass and endovascular revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late occlusion
Time Frame: 2 years
Late occlusion of the affected vessels
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egyptian Biomedical Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2014

Primary Completion (Actual)

April 17, 2019

Study Completion (Actual)

April 17, 2019

Study Registration Dates

First Submitted

July 24, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBRN71

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Critical Lower Limb Ischemia

Clinical Trials on long surgical bypass

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe