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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06260475
• Other study ID #: IUA - 246-18
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortoiliac Atherosclerosis
• Aortoiliac Obstruction
• Aortoiliac Occlusive Disease
• Atherosclerosis
• Gangrene
• Leriche Syndrome
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Procedure:
• Aortobifemoral bypass
Open surgery with aortic and iliac reconstruction
• 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

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Universitário de São João, EPE	Porto
Portugal	Faculdade de Medicina da Universidade do Porto	Porto

Sponsors (9)

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

Country where clinical trial is conducted

Portugal, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intensive care unit instay	Intensive care unit instay - days)	until 30 days
Other	acute kidney injury (AKI)	AKI according to Riffle criteria	until 30 days
Primary	Major Amputation	Amputation above the ankle	through study completion, an average of 3 years
Primary	Cardiovascular Death	Death from cardiovascular disease	through study completion, an average of 3 years
Primary	acute myorcardial infartion	According to the 4th definition of Myocardial infarction	through study completion, an average of 3 years
Secondary	Major Adverse Limb Events	Amputation above the ankle, arterial thrombosis of the limb, binary restenosis	through study completion, an average of 3 years
Secondary	Major adverse cardiovascular events	acute myocardial infarction; acute heart faillure, cardiovascular death, coronary reintervention	through study completion, an average of 3 years
Secondary	Death	Diagnosed by a physician	through study completion, an average of 3 years