Evaluating the effectiveness of endovascular treatment for aortoiliac occlusive disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the intermediate and long-term efficacy of endovascular treatment for patients with TASC C&D aortoiliac occlusive disease. Approximately 800 subjects will be enrolled across nine centers from April 2021 to June 2027, with follow-up lasting 60 months. The study will evaluate outcomes such as freedom from target lesion revascularization (TLR) at the 60-month mark, utilizing various endovascular techniques without restrictions. The research addresses the current controversies surrounding optimal treatment options for this condition, which have been based on limited data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Rutherford grades 3-6.
2. Follow the follow-up arrangement.
3. Age: 18-80 years old.
4. The target lesions were in the lower abdominal aorta and/or the common iliac artery and/or the external iliac artery.
5. The stenosis degree ≥50%, or restenosis (received PTA or other adjuvant therapy, including bare or covers stents), or complete occlusion, or the presence of aortailiac artery thrombosis after PMT or CDT thrombus clearance, and then further endovascular therapy perfomred.
6. Signed informed consent.

Exclusion Criteria:

1. Known allergy to drugs used in this study, including antiplatelet or anticoagulant drugs, etc.
2. Allergy to iodine contrast agent allergy;
3. Coagulation dysfunction or hypercoagulability;
4. Breast-feeding or pregnant women;
5. Life expectancy \< 24 months;
6. Body condition can not tolerate endovascular treatment;
7. Type 2B, type 3 lower limb ischemia patients

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Zhenyu Shi, MD,PhD
• Email: shizhenyumax@163.com
• Phone: +86021-64041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.