Clinical trial NCT04966767: Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease
Official title: Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease: a Prospective, Multicenter, Real-world, Registry Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peripheral Arterial Disease
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: First Affiliated Hospital of Zhejiang University
name: Chengdu University of Traditional Chinese Medicine
name: Xuanwu Hospital, Beijing
name: First People's Hospital of Hangzhou
name: Qingdao Hiser Medical Group
name: Second Affiliated Hospital of Soochow University
name: Huashan Hospital
First posted: 2021-07-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with TASC C\&D aortoiliac occlusive disease

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Free from clinically-drived target lesion reintervention
timeFrame: 5 years
Secondary outcomes:
measure: Technique success rate
timeFrame: 30 days
measure: Perioperative adverse events
timeFrame: 30 days
measure: Primary patency rate
timeFrame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Incidence of adverse blood supply events
timeFrame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Vascular quality of life questionnaire(VascuQol)
timeFrame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Total Cost of treatment
timeFrame: 3 years, 5 years
Other outcomes:
Locations:
Study officials:
References: