Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease: a Prospective, Multicenter, Real-world, Registry Study
Overview
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.
Primary outcome measures
- Free from clinically-drived target lesion reintervention [Time frame: 5 years]
Secondary outcome measures (6)
- Technique success rate [Time frame: 30 days]
- Perioperative adverse events [Time frame: 30 days]
- Primary patency rate [Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
- Incidence of adverse blood supply events [Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
- Vascular quality of life questionnaire(VascuQol) [Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
- Total Cost of treatment [Time frame: 3 years, 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04966767 · B2021-426