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Clinical Trials/NCT06260475
NCT06260475
Not yet recruiting
Not Applicable

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

Universidade do Porto2 sites in 1 country500 target enrollmentMarch 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortoiliac Atherosclerosis
Sponsor
Universidade do Porto
Enrollment
500
Locations
2
Primary Endpoint
acute myorcardial infartion
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

João Rocha Neves

Clinical Professor

Universidade do Porto

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)

Outcomes

Primary Outcomes

acute myorcardial infartion

Time Frame: through study completion, an average of 3 years

According to the 4th definition of Myocardial infarction

Major Amputation

Time Frame: through study completion, an average of 3 years

Amputation above the ankle

Cardiovascular Death

Time Frame: through study completion, an average of 3 years

Death from cardiovascular disease

Secondary Outcomes

  • 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)

Study Sites (2)

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