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Clinical Trials in China / NCT05391815
Recruiting Observational

This Study is a Prospective, Multi-center, Real World, Observational Study, Which Aims at Evaluating Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease.

NCT05391815 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Observational
Started
2021-04-01
Last updated
2022-05-26

Condition(s) studied

Peripheral Arterial Disease

Study summary

This study is a prospective, multi-center, real world, observational study, which aims at evaluating the intermediate and long-term efficacy of endovascular treatment for TASC C\&D aortoiliac occlusive disease .It is estimated that 800 subjects diagnosed with TASC C\&D aortoiliac occlusive disease and receive endovascular treatments will be enrolled in nine centers from April 2021 to June 2027 nation-widely. All the subjects will be under follow-up for 60 months. There is no restriction on the endovascular techniques. The primary outcomes covers freedom from TLR at 60 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital, Fudan University Shanghai China Recruiting

More Shanghai Zhongshan Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05391815 on ClinicalTrials.gov ↗ ← All trials in China