Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease

NCT ID: NCT04966767

Last Updated: 2021-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role collaborator

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role collaborator

Qingdao Hiser Medical Group

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Zhenyu Shi, MD, PhD

Role: CONTACT

0021 13564690539

Other Identifiers

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B2021-426

Identifier Type: -

Identifier Source: org_study_id

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