IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions

This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease; Peripheral Vascular Diseases; Aortoiliac Occlusive Disease; Aortoiliac Obstruction; Aortoiliac Atherosclerosis; Aortoiliac Atherosclerosis With Gangrene; Aortoiliac Atherosclerosis Without Gangrene
• Intervention / Treatment: Procedure: Aortobifemoral bypass; Procedure: aortoiliac stenting

Detailed Description

Open surgery repair with Aortobifemoral Bypass (ABF) remains the gold standard revascularization technique in patients with lifestyle-limiting intermittent claudication (IC) and chronic limb-threatening ischemia due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type D lesions

The ABF procedure has proven safe, effective, and durable, particularly considering its high long-term patency rates (85%-90% at five years and 75%-80% at ten years) despite its significant peri-operative associated morbidity (1). On the other hand, endovascular treatment (EVT) offers an attractive alternative with durable results (four- or 5-year primary and secondary patency rates ranged from 60% to 86% and 80% to 98%, respectively), especially in less extensive AIOD, while also providing less perioperative morbidity, making it generally preferable for patients with more severe comorbid conditions.

Thus, surgical approaches to extensive AIOD have changed considerably over the last years, primarily due to increased EVT, particularly with the uncovered aortoiliac stenting (AIS). While TASC II provides an anatomical framework to compare therapeutic techniques, 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. It is attractive for patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to ABF

This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II).

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Faculdade de Medicina da Universidade do Porto
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitário de São João, EPE
    • Contact: Joao Rocha-Neves; Phone Number: +351910486230; Email: joaorochaneves@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing revascularization of the aorto-iliac sector for peripheral arterial disease at any of the center in study starting in January 2016 until December 2023.A consecutive sample will be prepared, containing all patients at the recruiting centers, fulfilling the following criteria

Description

Inclusion Criteria:

• Patients with peripheral arterial/atherosclerotic disease of the aorto-iliac sector undergoing direct, hybrid or endovascular surgical correction with TransAtlantic Inter-Society Consensus (TASC II) type D classification(12).

  • Age >18 years old

Exclusion Criteria:

• Synchronous aortoiliac aneurysmatic/ectasic disease (aorta AP diameter >25 mm)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with symptomatic peripheral artery disease and aortoiliac obstrutive disease; Chronic limb-threatening ischemia or claudicants due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type C and D lesions

Procedure: Aortobifemoral bypass; Open surgery with aortic and iliac reconstruction; Other Names: aortobiliac bypass; Procedure: aortoiliac stenting; Endovascular reconstruction of aortic and iliac arterial obstruction: Balloon angioplasty may be performed initially to dilate the narrowed segment of the iliac artery. Subsequently, a stent delivery system is advanced over the wire and positioned across the lesion. The stent is deployed under fluoroscopic guidance to expand and scaffold the diseased artery, restoring blood flow. Vascular - iliac dedicated Stent - any brand; Other Names: Percutaneous transluminal aortoiliac stenting; Endovascular treatment of aortoiliac occlusive disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Amputation	Amputation above the ankle	through study completion, an average of 3 years
Cardiovascular Death	Death from cardiovascular disease	through study completion, an average of 3 years
acute myorcardial infartion	According to the 4th definition of Myocardial infarction	through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Limb Events	Amputation above the ankle, arterial thrombosis of the limb, binary restenosis	through study completion, an average of 3 years
Major adverse cardiovascular events	acute myocardial infarction; acute heart faillure, cardiovascular death, coronary reintervention	through study completion, an average of 3 years
Death	Diagnosed by a physician	through study completion, an average of 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive care unit instay	Intensive care unit instay - days)	until 30 days
acute kidney injury (AKI)	AKI according to Riffle criteria	until 30 days

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: University of Trieste; University of Padova; Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro; Centro Hospitalar de Vila Nova de Gaia/Espinho; Clinical Centre of Serbia; University of Bari; Centro Hospitalar do Porto; University of Nis

Publications and helpful links

General Publications

• Jongkind V, Akkersdijk GJ, Yeung KK, Wisselink W. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. J Vasc Surg. 2010 Nov;52(5):1376-83. doi: 10.1016/j.jvs.2010.04.080.
• Groot Jebbink E, Holewijn S, Slump CH, Lardenoije JW, Reijnen MMPJ. Systematic Review of Results of Kissing Stents in the Treatment of Aortoiliac Occlusive Disease. Ann Vasc Surg. 2017 Jul;42:328-336. doi: 10.1016/j.avsg.2017.01.009. Epub 2017 Apr 6.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Estimated): February 15, 2024

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: peripheral artery disease;; aortobifemoral bypass;; aortoiliac stenting;; preoperative care
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Diseases; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Gangrene; Leriche Syndrome
• Other Study ID Numbers: IUA - 246-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The anonymity and confidentiality of participants will be safeguarded. The patient will be entered without any reference to their name. The participant number will correspond to the clinical information in a separate database, which will only be used for the proposed objective after supervision by the PI and Supervisor. For analysis purposes, the participant number will be deleted.

All information entered in the database will be constant in the clinical process.

The results may be published in a scientific journal and/or congress. Rules of Ethical Conduct and Good Practices will be observed to ensure compliance with the precepts of the Declaration of Helsinki, the Convention on Human Rights and Biomedicine, the guidelines of the Council for International Organizations of Medical Sciences and the Guide to Good Clinical Practices.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes