Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease (ALLIANCE)

Fudan University

Status: Not yet enrolling

Conditions: Peripheral Arterial Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04966767

B2021-426

Details and patient eligibility

About

This is a prospective, multicenter, real-world, registry study, which aims to observe the intermediate and long-term efficacy of different endovascular treatments for TASC C&D aortoiliac occlusive disease.

Full description

Currently, the optimal therapy for TASC C and D type aortic occlusive disease is still controversial. The evidence comes from several singe-center studies with small sample size. In addition, the long-term efficacy of stent implantation and drug coated device in aortic occlusive disease remains unclear, which might be affected by the type of stent and calcification extent. Thus, this study aims to observe the intermediate and long-term efficacy of different endovascular treatments for TASC C&D aortoiliac occlusive disease in multiple centers.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rutherford classification of 3-6
• Willing to comply with all follow-up evaluations at the specified times
• Target lesion(s) located within the native infrarenal abdominal aorta and/or common iliac artery and/or external iliac artery
• Evidence of ≥ 50% stenosis, restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s), or arterial thrombosis underwent PMT or CDT
• Provides written informed consent

Exclusion criteria

• Contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, or any other drug used during the study
• Known hypersensitivity to contrast material that cannot be adequately pretreated
• Bleeding diathesis or coagulopathy, known hypercoagulable condition or refuses blood transfusion
• Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures
• Life expectancy less than 24 months
• Current participation in an investigational drug or other device study
• Severe comorbid conditions
• Myocardial infarction or stroke within 3 months prior to enrollment