Evaluating the effectiveness of endovascular treatment for aortoiliac occlusive disease

Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease: a Prospective, Multicenter, Real-world, Registry Study

This study is testing how well a new endovascular treatment works for people with aortoiliac occlusive disease over the long term.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05391815 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with Rutherford grades 3-6 and significant stenosis or occlusion in the aortoiliac region.

Not a fit: Patients with known allergies to study-related medications, severe coagulation disorders, or those who cannot tolerate endovascular treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of endovascular treatments, potentially improving patient outcomes for those with aortoiliac occlusive disease.

How similar studies have performed: While there have been studies on endovascular treatments, this multicenter approach specifically targeting TASC C&D lesions is relatively novel.

Eligibility criteria

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 this trial is running

Shanghai

• Zhongshan Hospital, Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Zhenyu Shi, MD,PhD

Conditions Peripheral Arterial Disease; Aortoiliac Occlusive Disease