Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.

Critical Limb Ischemia Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04974905
• Other study ID #: Soh-Med-21-07-22
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: July 2021
• Source: Sohag University
• Contact: Mostafa A Foda, Msc
• Phone: 01012514518
• Email: m_foda_revolution2020[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Critical Limb Ischemia
• Ischemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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