Clinical trial NCT04974905: Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.
Official title: Retrograde Approach for Management of Infrainguinal Arterial Occlusive Disease After Failed Antegrade Approach in Critical Limb Ischemia Patients; Feasibility, Safety, and Procedure Related Outcomes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Limb Ischemia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: safety of retrograde approach as regard occurrence of procedure specific complications
timeFrame: within one year of follow up
measure: feasibility of retrograde approach as regard successful retrograde puncture and technical success after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease.
timeFrame: within one year of follow up
Secondary outcomes:
measure: clinical success of the procedure
timeFrame: within one year of follow up
measure: One year limb salvage rate of the procedure
timeFrame: within one year of follow up
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.