Actively Recruiting
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.
Led by Shanghai Zhongshan Hospital · Updated on 2022-05-26
800
Participants Needed
1
Research Sites
582 weeks
Total Duration
On this page
Sponsors
S
Shanghai Zhongshan Hospital
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Rutherford grades 3-6.
- Will follow the study's follow-up schedule.
- Age between 18 and 80 years old.
- Target artery lesions in the lower abdominal aorta, common iliac artery, or external iliac artery.
- Artery narrowing of 50% or more, restenosis after prior treatments including PTA or stenting, complete occlusion, or aortoiliac artery thrombosis cleared by thrombus removal and treated further with endovascular therapy.
- Signed informed consent to participate in the study.
You will not qualify if you...
- Known allergy to drugs used in the study, including antiplatelet or anticoagulant medications.
- Allergy to iodine contrast agents.
- Coagulation problems or tendency to form clots.
- Pregnant or breastfeeding women.
- Life expectancy less than 24 months.
- Medical condition that prevents tolerating endovascular treatment.
- Patients with type 2B or type 3 lower limb ischemia.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
Research Team
Z
Zhenyu Shi, MD,PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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