Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.

Not Applicable

• Conditions: Critical Limb Ischemia
• Interventions: Procedure: retrograde access for re-canalization of infra-inguinal arterial occlusive disease

• Registration Number: NCT04974905
• Lead Sponsor: Sohag University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-15
• Last Update Submitted: 2021-07-15
• Study First Posted: 2021-07-23
• Last Update Posted: 2021-07-23
• Study Start: 2021-08-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with infrainguinal arterial occlusive disease after failed antegrade approach	retrograde access for re-canalization of infra-inguinal arterial occlusive disease	-

Primary Outcome Measures

Name	Time	Method
safety of retrograde approach as regard occurrence of procedure specific complications	within one year of follow up	safety of retrograde approach after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease, in the light of complications which are classified into major or minor according to the reporting standards of society of vascular surgery.this complications will be looked for and data will be collected
feasibility of retrograde approach as regard successful retrograde puncture and technical success after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease.	within one year of follow up	it means that this approach can be used successfuly in clinical practice and this will be assessd by measuring successful retrograde puncture and technical success.; successful retrograde puncture means successful performance of retrograde puncture at any of the retrograde distal puncture sites with intraluminal placement of the retrograde guidewire confirmed by contrast angiography without causing procedure specific complications namely local dissection, rupture, or an arteriovenous fistula at puncture site.; technical success is defined as successful puncture followed by successful crossing of the occlusion and regain of inline flow to the foot with less than 30%residual stenosis after treatment.

Secondary Outcome Measures

Name	Time	Method
clinical success of the procedure	within one year of follow up	immediate clinical success is defined as regain of distal pulses, revascularization warmness and edema, and/or disappearance of rest pain.
One year limb salvage rate of the procedure	within one year of follow up	limb salvage is defined as healing of existing wounds with no amputation proximal to metatarsus.