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

NCT04966767 | Not Yet Recruiting

• 1 other identifier: B2021-426
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Free from clinically-drived target lesion reintervention

  TLR was defined as a reintervention performed for \>50% diameter stenosis or in the target lesion after documentation of recurrent clinical symptoms following the index procedure or bailout stenting during the index procedure. Freedom form TLR were defined as the rates of the number of patients who did not receive reintervention verse the number of patients during the follow-up period.

  5 years

Secondary Outcomes (6)

• Technique success rate

  30 days

• Perioperative adverse events

  30 days

• Primary patency rate

  6 months, 1 year, 2 years, 3 years, 4 years, 5 years

• Incidence of adverse blood supply events

  6 months, 1 year, 2 years, 3 years, 4 years, 5 years

• Vascular quality of life questionnaire(VascuQol)

  6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with TASC C\&D aortoiliac occlusive disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• RenJi Hospital: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator
• Xuanwu Hospital, Beijing: collaborator
• First People's Hospital of Hangzhou: collaborator
• Qingdao Hiser Medical Group: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• Huashan Hospital: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Zhenyu Shi, MD, PhD

CONTACT

0021 13564690539; maxshizhenyu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 19, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 19, 2021

Record last verified: 2021-07