Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia

NCT ID: NCT04490408

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-20

Study Completion Date

2019-04-17

Brief Summary

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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

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Conditions

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Critical Lower Limb Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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long surgical bypass

long surgical bypass for multilevel lower limb ischemia

Group Type ACTIVE_COMPARATOR

long surgical bypass

Intervention Type PROCEDURE

long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.

Hybrid approach

surgical bypass and endovascular treatment for multilevel lower limb ischemia

Group Type EXPERIMENTAL

Hybrid approach

Intervention Type PROCEDURE

Hybrid approach including bypass and endovascular revascularization

Interventions

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long surgical bypass

long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.

Intervention Type PROCEDURE

Hybrid approach

Hybrid approach including bypass and endovascular revascularization

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Egyptian Biomedical Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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EBRN71

Identifier Type: -

Identifier Source: org_study_id

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