Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.

Study Overview
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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.

Official Title
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Retrograde Approach for Management of Infrainguinal Arterial Occlusive Disease After Failed Antegrade Approach in Critical Limb Ischemia Patients; Feasibility, Safety, and Procedure Related Outcomes.

Conditions
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Critical Limb Ischemia

Intervention / Treatment
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* Procedure: retrograde access for re-canalization of infra-inguinal arterial occlusive disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with; CLI consistent with Rutherford categories (4-5). 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: Non-salvageable limbs. Life threatening infections requiring major amputation. Ulcers at the area of intended puncture.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients with infrainguinal arterial occlusive disease after failed antegrade approach<br> | Procedure: retrograde access for re-canalization of infra-inguinal arterial occlusive disease<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of retrograde approach as regard occurrence of procedure specific complications | 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 | within one year of follow up | 
| feasibility of retrograde approach as regard successful retrograde puncture and technical success after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease. | 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. | within one year of follow up | 

Secondary Outcome Measures

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