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.

Recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT05391815
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2021-04-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-23
• Last Update Submitted: 2022-05-23
• Study First Posted: 2022-05-26
• Last Update Posted: 2022-05-26
• Primary Completion: 2027-06-01
• Study Completion: 2032-06-01

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from clinically-driven TLR	60 months	CD-TLR was defined as any reintervention within the target lesion(s) because of recurrent symptoms. Freedom form CD-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
Incidence of major adverse events.	1month, 3 months,6 months, 12 months ,24 months	Major 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.
Health economics evaluation	60 months	All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.
CD-TLR	1 month, 3 months, 6 months, 12 months, 24 months, 36 months	CD-TLR was defined as any reintervention within the target lesion(s) because of recurrent symptoms.
Vascular quality of life questionnaire(VascuQol)	1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months	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.
Technical success rate	30 days	We defined the technical success rate as the rate of patients in whom the endovascular treatments are successfully performed.
Adverser events related to insufficient lower limb blood supply.	1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months	Major amputation, acute re-occlusion, subacute re-occlusion and chronic re-occlusion.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China