Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.

NCT04974905 | Unknown

• 1 other identifier: Soh-Med-21-07-22
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• clinical success of the procedure

  within one year of follow up

• One year limb salvage rate of the procedure

  within one year of follow up

Study Arms (1)

patients with infrainguinal arterial occlusive disease after failed antegrade approach

OTHER

Procedure: retrograde access for re-canalization of infra-inguinal arterial occlusive disease

Interventions

retrograde access for re-canalization of infra-inguinal arterial occlusive disease PROCEDURE

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

patients with infrainguinal arterial occlusive disease after failed antegrade approach

Eligibility Criteria

• Age: 35 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• patients with the following conditions will be excluded:
• Non-salvageable limbs.
• Life threatening infections requiring major amputation.
• Ulcers at the area of intended puncture.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (3)

• 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.

  PMID: 31834669 BACKGROUND

• 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.

  PMID: 25241321 BACKGROUND

• 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.

  PMID: 24650744 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Mostafa A Foda, Msc

CONTACT

01012514518; m_foda_revolution2020@yahoo.com

Hussein K Hussein, Professor

CONTACT

01222142667

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer in the department of vascular surgery

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 23, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 23, 2021

Record last verified: 2021-07