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

NCT06260475 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IUA - 246-18
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Aortoiliac Atherosclerosis; Aortoiliac Occlusive Disease; Aortoiliac Atherosclerosis With Gangrene; Aortoiliac Atherosclerosis Without Gangrene; Aortoiliac Obstruction; Peripheral Arterial Disease; Peripheral Vascular Diseases

Keywords

peripheral artery disease;; aortobifemoral bypass;; aortoiliac stenting;; preoperative care;

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Major Adverse Limb Events

  through study completion, an average of 3 years

• Major adverse cardiovascular events

  through study completion, an average of 3 years

• Death

  through study completion, an average of 3 years

Other Outcomes (2)

• Intensive care unit instay

  until 30 days

• acute kidney injury (AKI)

  until 30 days

Study Arms (1)

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; Procedure: aortoiliac stenting

Interventions

Aortobifemoral bypass PROCEDURE

Open surgery with aortic and iliac reconstruction

Also known as: aortobiliac bypass

Patients with symptomatic peripheral artery disease and aortoiliac obstrutive disease

aortoiliac stenting PROCEDURE

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

Also known as: Percutaneous transluminal aortoiliac stenting; Endovascular treatment of aortoiliac occlusive disease

Patients with symptomatic peripheral artery disease and aortoiliac obstrutive disease

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Centro Hospitalar Universitário de São João, EPE

Porto, 4200-319, Portugal

Location

Faculdade de Medicina da Universidade do Porto

Porto, 4200-319, Portugal

Location

Related Publications (2)

• 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.

  PMID: 20598474 BACKGROUND

• 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.

  PMID: 28390920 BACKGROUND

MeSH Terms

Conditions

Leriche Syndrome; Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: February 15, 2024
• Study Start: March 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)