Clinical trial NCT05391815: This Study is a Prospective, Multi-center, Real World, Observational Study, Which Aims at Evaluating Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease.
Official title: Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease: a Prospective, Multicenter, Real-world, Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Keywords: Aortoiliac Occlusive Disease
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: First Affiliated Hospital of Zhejiang University
name: Chengdu University of Traditional Chinese Medicine
name: Xuanwu Hospital, Beijing
name: First People's Hospital of Hangzhou
name: Qingdao Hiser Medical Group
name: Second Affiliated Hospital of Soochow University
name: Liyuan Hospital of Tongji Medical College of Huazhong University of Science and Technology
name: Huashan Hospital
First posted: 2022-05-26
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The TASC C\&D Aorta-iliac occlusion patients.

Brief summary: This study is a prospective, multi-center, real world, observational study, which aims at evaluating the intermediate and long-term efficacy of endovascular treatment for TASC C\&D aortoiliac occlusive disease .It is estimated that 800 subjects diagnosed with TASC C\&D aortoiliac occlusive disease and receive endovascular treatments will be enrolled in nine centers from April 2021 to June 2027 nation-widely. All the subjects will be under follow-up for 60 months. There is no restriction on the endovascular techniques. The primary outcomes covers freedom from TLR at 60 months.

Detailed description: In the past decade, endovascular treatment has become the first-line treatment for iliac artery occlusion, while Aorta - bilateral femoral artery bypass surgery is preferred for more complex iliac artery occlusion. However, recently, with advances in endovascular devices and techniques, endovascular interventions have gradually replaced open surgery in many clinical problems and have shown ideal safety and efficacy.

Currently, the optimal treatment for TASC, C\&D iliac artery occlusion is controversial, mostly based on limited data from single centers and few large multicenter databases or registries. In addition, the long-term efficacy of stents implantation in iliac artery disease remind unknown and might be influenced by stent type and calcification. Therefore, the purpose of this study was to evaluate the long-term efficacy and safety of endovascular treatment for TASC, C\&D iliac artery occlusion in a multicenter study.

Eligibility criteria: Inclusion Criteria:

1. Rutherford grades 3-6.
2. Follow the follow-up arrangement.
3. Age: 18-80 years old.
4. The target lesions were in the lower abdominal aorta and/or the common iliac artery and/or the external iliac artery.
5. The stenosis degree ≥50%, or restenosis (received PTA or other adjuvant therapy, including bare or covers stents), or complete occlusion, or the presence of aortailiac artery thrombosis after PMT or CDT thrombus clearance, and then further endovascular therapy perfomred.
6. Signed informed consent.

Exclusion Criteria:

1. Known allergy to drugs used in this study, including antiplatelet or anticoagulant drugs, etc.
2. Allergy to iodine contrast agent allergy;
3. Coagulation dysfunction or hypercoagulability;
4. Breast-feeding or pregnant women;
5. Life expectancy \< 24 months;
6. Body condition can not tolerate endovascular treatment;
7. Type 2B, type 3 lower limb ischemia patients

Primary outcomes:
measure: Freedom from clinically-driven TLR
timeFrame: 60 months
Secondary outcomes:
measure: Technical success rate
timeFrame: 30 days
measure: Incidence of major adverse events.
timeFrame: 1month, 3 months,6 months, 12 months ,24 months
measure: Adverser events related to insufficient lower limb blood supply.
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: CD-TLR
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
measure: Vascular quality of life questionnaire(VascuQol)
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Health economics evaluation
timeFrame: 60 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
References:
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