Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.

Sohag University

Status: Unknown

Conditions: Critical Limb Ischemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04974905

Soh-Med-21-07-22

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 35 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

patients with infrainguinal arterial occlusive disease after failed antegrade approach

Other group

Treatment:

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