Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-08-01

Brief Summary

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The spectrum of lower extremity peripheral arterial disease (PAD) ranges from exhibiting no symptoms to limb threatening gangrene. The number of patients living with it is rising steadily owing to increased life expectancy, obesity, diabetes, and tobacco consumption.

Critical limb ischemia (CLI) is the terminal and the most serious stage of PAD in which blood flow to the lower extremity does not meet metabolic demands of the tissues at rest. The diagnosis is mainly clinical and patients are presented with rest pain, minimal tissue loss or frank gangrene.

Revascularization strategies include endovascular procedures and surgical bypass.Endovascular therapy has evolved as an attractive, minimally invasive method of revascularization especially in the more frequently encountered patients with medical and anatomical contraindications to surgical revascularization.

Antegrade approach is the standard approach in infrainguinal arterial occlusive disease,however, failure occurs in about 20% of infrainguinal attempts.Retrograde approach is used as a backup technique in failed cases.

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Detailed Description

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Conditions

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Critical Limb Ischemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients with infrainguinal arterial occlusive disease after failed antegrade approach

Group Type OTHER

retrograde access for re-canalization of infra-inguinal arterial occlusive disease

Intervention Type PROCEDURE

after failed antegrade approach for re-canalization of infra-inguinal arterial occlusive disease( failed reentry into the distal true lumen), the retrograde approach will be attempted

Interventions

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retrograde access for re-canalization of infra-inguinal arterial occlusive disease

after failed antegrade approach for re-canalization of infra-inguinal arterial occlusive disease( failed reentry into the distal true lumen), the retrograde approach will be attempted

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

patients with;

1. CLI consistent with Rutherford categories (4-5).
2. Infrainguinal arterial occlusive disease with a patent distal part of at least one tibial vessel runoff to the foot.

Exclusion Criteria

patients with the following conditions will be excluded:

1. Non-salvageable limbs.
2. Life threatening infections requiring major amputation.
3. Ulcers at the area of intended puncture.

Minimum Eligible Age

35 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No