Clinical trial NCT06260475: IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions
Official title: IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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;
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Clinical Centre of Serbia
name: University of Padova
name: University of Bari
name: University of Trieste
name: University of Nis
name: Centro Hospitalar de Vila Nova de Gaia/Espinho
name: Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
name: Centro Hospitalar do Porto
First posted: 2024-02-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Major Amputation
timeFrame: through study completion, an average of 3 years
measure: Cardiovascular Death
timeFrame: through study completion, an average of 3 years
measure: acute myorcardial infartion
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Major Adverse Limb Events
timeFrame: through study completion, an average of 3 years
measure: Major adverse cardiovascular events
timeFrame: through study completion, an average of 3 years
measure: Death
timeFrame: through study completion, an average of 3 years
Other outcomes:
measure: Intensive care unit instay
timeFrame: until 30 days
measure: acute kidney injury (AKI)
timeFrame: until 30 days
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de São João, EPE
city: Porto
country: Portugal
facility: Faculdade de Medicina da Universidade do Porto
Study officials:
References:
citation: 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.
citation: 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.