Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Procedure: retrograde access for re-canalization of infra-inguinal arterial occlusive disease

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa A Foda, Msc; Phone Number: 01012514518; Email: m_foda_revolution2020@yahoo.com
• Study Contact Backup: Name: Hussein K Hussein, Professor; Phone Number: 01222142667

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients with infrainguinal arterial occlusive disease after failed antegrade approach	Procedure: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Mustapha JA, Saab F, McGoff TN, Adams G, Mullins JR, Al-Dadah A, Jaff MR, Goodney PP, Khawaja F, Diaz-Sandoval LJ. Tibiopedal arterial minimally invasive retrograde revascularization (TAMI) in patients with peripheral arterial disease and critical limb ischemia. On behalf of the Peripheral Registry of Endovascular Clinical Outcomes (PRIME). Catheter Cardiovasc Interv. 2020 Feb 15;95(3):447-454. doi: 10.1002/ccd.28639. Epub 2019 Dec 13.
• Hendricks NJ, Sabri SS. Subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) and rertograde access for critical limb ischemia. Tech Vasc Interv Radiol. 2014 Sep;17(3):203-10. doi: 10.1053/j.tvir.2014.08.009. Epub 2014 Sep 4.
• Bazan HA, Le L, Donovan M, Sidhom T, Smith TA, Sternbergh WC 3rd. Retrograde pedal access for patients with critical limb ischemia. J Vasc Surg. 2014 Aug;60(2):375-81. doi: 10.1016/j.jvs.2014.02.038. Epub 2014 Mar 18.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Ischemia; Arterial Occlusive Diseases
• Other Study ID Numbers: Soh-Med-21-07-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No