Treatment of TASC C and D Aortoiliac Lesions

NCT06253312 | Recruiting

• 1 other identifier: Complex aortoiliac lesions
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The treatment of patients with complex aortoiliac disease (AID), classified as Trans-Atlantic Inter-Society consensus II (TASC) class C and D, presents a dilemma for vascular surgeons. Current guidelines recommend either open surgical reconstruction (OR), hybrid repair (HR) combining iliac stenting with femoral endarterectomy, or total endovascular repair (ER). While traditional OR with aortobifemoral bypass (ABF) is associated with excellent long term patency results, it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8%. The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to OR. Aim: The aim of this trial is to evaluate the short, mid-, and long-term results of open repair, hybrid and endovascular repair in the treatment patients with complex, TASC C and D, aortoiliac lesions. Methodology: This is a retrospective cohort study planning to include vascular surgery centers from the following countries: Italy, Portugal, Spain, and Serbia. Data will be collected on demographics, baseline comorbidities, anatomy and morphology of the aortoiliac and femoral bifurcation disease, intraoperative, postoperative, and follow-up data. Propensity score analysis will be performed by matching open repair patients in all three groups (open, hybrid, and endovascular repair) controlling for demographics, baseline comorbidities, anatomical and morphological data. Endpoints: Primary endpoints are all-cause mortality and the major adverse limb events (major amputation - below and above the knee, new onset acute limb ischaemia, reintervention of the treated arterial segment). The secondary endpoints are the 30-day complications and primary patency.

Conditions

Peripheral Arterial Disease; Aortoiliac Occlusive Disease; Leriche Syndrome; Peripheral Vascular Disease

Keywords

peripheral arterial disease; aortoiliac disease; TASC C,D; open surgery; hybrid repair; endovascular repair; atherosclerosis

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  Overall mortality in all treatment arms

  Short-term (30-days), mid-term (between 1-5 years), long-term (more than 5 years)

• Major adverse limb event (MALE)

  Major amputations (below and above the knee), new onset acute limb ischaemia of the treated extremity, and reintervention on the already treated arterial segment (aortoiliac segment and femoral bifurcation, excluding distal infrainguinal disease).

  Short-term (30-days), mid-term (between 1-5 years), long-term (more than 5 years)

Secondary Outcomes (2)

• 30-day complication

  Short-term (30-days)

• Primary patency

  Short-term (30-days), mid-term (between 1-5 years), long-term (more than 5 years)

Study Arms (3)

Open surgery

Patients with complex TASC C and D aortoiliac occlusive disease undergoing open surgery: aortobifemoral bypass, crossover bypass, axillobifemoral bypass, aortoiliac endarterectomy, iliofemoral bypass

Procedure: Open surgery

Hybrid repair

Patients with complex TASC C and D aortoiliac occlusive disease undergoing simultaneous open surgical femoral artery reconstruction (endarterectomy, bypass, profundoplasty) and stenting of the iliac axis

Procedure: Hybrid repair

Endovascular repair

Patients with complex TASC C and D aortoiliac occlusive disease undergoing total endovascular repair using different material: bare metal stents (self and balloon expandable), stent-grafts (self and balloon expandable), covered endovascular reconstruction of aortic bifurcation (CERAB), simple plain old balloon angioplasty (POBA)

Procedure: Endovascular repair

Interventions

Open surgery PROCEDURE

Patients with complex TASC C and D aortoiliac occlusive disease undergoing open surgery: aortobifemoral bypass, crossover bypass, axillobifemoral bypass, aortoiliac endarterectomy, iliofemoral bypass

Also known as: Aortobifemoral bypass, Crossover bypass, Axillobifemoral bypass, Aortoiliac endarterectomy, Iliofemoral bypass

Open surgery

Hybrid repair PROCEDURE

Patients with complex TASC C and D aortoiliac occlusive disease undergoing simultaneous open surgical femoral artery reconstruction (endarterectomy, bypass, profundoplasty) and stenting of the iliac axis

Also known as: Iliac stenting, Femoral endarterectomy

Hybrid repair

Endovascular repair PROCEDURE

Patients with complex TASC C and D aortoiliac occlusive disease undergoing total endovascular repair using different material: bare metal stents (self and balloon expandable), stent-grafts (self and balloon expandable), covered endovascular reconstruction of aortic bifurcation (CERAB), simple plain old balloon angioplasty (POBA)

Also known as: Bare metal stenting, Covered stent, Plain old balloon angioplasty

Endovascular repair

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with peripheral arterial disease according to the Rutherford classification system (with claudications and chronic-limb threatening ischemia) undergoing one of the three available treatment option: * Open surgery (aortobifemoral bypass, aortoiliac endarterectomy, iliacofemoral bypass, crossover bypass, axillobifemoral bypass) * Hybrid repair (iliac artery stenting and common femoral artery reconstruction) * Endovascular repair (bare metal stenting, using covered stents, and plain balloon angioplasty)

You may qualify if:

• All patients (over 18 years of age) with a history of atherosclerotic peripheral arterial disease treated between 1st January 2015 and 1st January 2022
• All management strategies will be included (endovascular, hybrid, and open)

You may not qualify if:

• Patients who are pregnant
• Patients who are under 18 years of age
• Patients who have acute limb ischemia or acute on chronic ischemia
• Non-atherosclerotic origin of disease: cyclist disease, trauma, dissection
• Patients who were treated in conservative manner
• Patients who underwent primary major amputation
• Patients with limited life expectancy (less than 2 years)

Sponsors & Collaborators

• Clinical Centre of Serbia: lead
• University of Belgrade: collaborator
• University of Trieste: collaborator
• Centro Hospitalar De São João, E.P.E.: collaborator
• Clinical Center Nis, University of Nis: collaborator
• Clinical Center Novi Sad, University of Novi Sad: collaborator
• Institute for Cardiovascular Diseases Dedinje: collaborator

Study Sites (1)

Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

Related Publications (5)

• Antonello M, Squizzato F, Bassini S, Porcellato L, Grego F, Piazza M. Open repair versus endovascular treatment of complex aortoiliac lesions in low risk patients. J Vasc Surg. 2019 Oct;70(4):1155-1165.e1. doi: 10.1016/j.jvs.2018.12.030. Epub 2019 Mar 6.

  PMID: 30850298 RESULT

• Mayor J, Branco BC, Chung J, Montero-Baker MF, Kougias P, Mills JL Sr, Gilani R. Outcome Comparison between Open and Endovascular Management of TASC II D Aortoiliac Occlusive Disease. Ann Vasc Surg. 2019 Nov;61:65-71.e3. doi: 10.1016/j.avsg.2019.06.005. Epub 2019 Aug 6.

  PMID: 31394230 RESULT

• Starodubtsev V, Mitrofanov V, Ignatenko P, Gostev A, Preece R, Rabtsun A, Saaya S, Popova I, Karpenko A. Editor's Choice - Hybrid vs. Open Surgical Reconstruction for Iliofemoral Occlusive Disease: A Prospective Randomised Trial. Eur J Vasc Endovasc Surg. 2022 Apr;63(4):557-565. doi: 10.1016/j.ejvs.2022.02.002. Epub 2022 Feb 9.

  PMID: 35283003 RESULT

• Suzuki K, Mizutani Y, Soga Y, Iida O, Kawasaki D, Yamauchi Y, Hirano K, Koshida R, Kamoi D, Tazaki J, Higashitani M, Shintani Y, Yamaoka T, Okazaki S, Suematsu N, Tsuchiya T, Miyashita Y, Shinozaki N, Takahashi H, Inoue N. Efficacy and Safety of Endovascular Therapy for Aortoiliac TASC D Lesions. Angiology. 2017 Jan;68(1):67-73. doi: 10.1177/0003319716638005. Epub 2016 Mar 15.

  PMID: 26980775 RESULT

• Squizzato F, D'Oria M, Bozza R, Porcellato L, Grego F, Lepidi S. Propensity-Matched Comparison of Endovascular versus Open Reconstruction for TASC-II C/D AortoIliac Occlusive Disease. A Ten-Year Single-Center Experience with Self-Expanding Covered Stents. Ann Vasc Surg. 2021 Feb;71:84-95. doi: 10.1016/j.avsg.2020.08.139. Epub 2020 Sep 11.

  PMID: 32927036 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease; Leriche Syndrome; Peripheral Vascular Diseases; Atherosclerosis

Interventions

Conversion to Open Surgery; Axillofemoral Bypass Grafting; Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Anastomosis, Surgical; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Endovascular Procedures; Blood Vessel Prosthesis Implantation; Vascular Grafting; Prosthesis Implantation

Study Officials

• Joao Rocha Neves, MD PhD

  Univeristy of Porto

  STUDY DIRECTOR

Central Study Contacts

Petar Zlatanovic, MD FEBVS

CONTACT

+381644961020; petar91goldy@gmail.com

Mario D'Oria, MD PhD

CONTACT

mario.doria88@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

SE (1)