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

Not yet recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT04966767
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-16
• Last Update Submitted: 2021-07-16
• Study First Posted: 2021-07-19
• Last Update Posted: 2021-07-19
• Study Start: 2021-08-01
• Primary Completion: 2027-07-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Free from clinically-drived target lesion reintervention	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Primary patency rate	6 months, 1 year, 2 years, 3 years, 4 years, 5 years	The primary patency rate was defined as the percentage of stent patency examined by ultrasonograpy or computed tomography angiography examination of lower limb arteries during follow-up.
Incidence of adverse blood supply events	6 months, 1 year, 2 years, 3 years, 4 years, 5 years	Incidence of adverse blood supply events include anyone of the following: acute or chronic occlusion of target lower extremity, major or minor amputation of a vascular etiology
Vascular quality of life questionnaire(VascuQol)	6 months, 1 year, 2 years, 3 years, 4 years, 5 years	The VascuQol was designed as a questionnaire containing five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items) to evaluate Health related quality of life (HRQL). Every item has seven response options, with scores ranging from 1 to 7. A total score is the sum of all 25 item scores divided by 25.And both the total score as well as the domain scores range from 1 (worst HRQL) to 7 (best HRQL).The lower the value, the poorer the quality of life.
Total Cost of treatment	3 years, 5 years	All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed. Health economics evaluation
Technique success rate	30 days	Successfully revascularize the target vessel. The residual stenosis is \<30% and there is no acute thrombosis occurred in the target vessel within 30 days post-operation. The Technical success rate was defined as the rate of the number of patients who receive the treatment as intended verse the number of the patients enrolled.
Perioperative adverse events	30 days	Perioperative adverse events include anyone of the following: all-cause mortality, Myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, and arterial thrombosis related to endovascular manipulation.