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

Peripheral Arterial Disease Clinical Trial

— ALLIANCE  

Official title:

Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease: a Prospective, Multicenter, Real-world, Registry Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04966767
• Other study ID #: B2021-426
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: July 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Zhenyu Shi, MD, PhD
• Phone: 0021 13564690539
• Email: maxshizhenyu[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Chengdu University of Traditional Chinese Medicine, First Affiliated Hospital of Zhejiang University, First People's Hospital of Hangzhou, Huashan Hospital, Qingdao Hiser Medical Group, RenJi Hospital, Second Affiliated Hospital of Soochow University, Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free from clinically-drived target lesion reintervention	TLR was de?ned 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	Technique success rate	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.	30 days
Secondary	Perioperative adverse events	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.	30 days
Secondary	Primary patency rate	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.	6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Incidence of adverse blood supply events	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	6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Vascular quality of life questionnaire(VascuQol)	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.	6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Total Cost of treatment	All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed. Health economics evaluation	3 years, 5 years