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.

Shanghai Zhongshan Hospital800 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

800

Conditions

Peripheral Arterial Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Freedom from clinically-driven TLR

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.

Time frame: 60 months

Secondary Outcomes

Technical success rate

We defined the technical success rate as the rate of patients in whom the endovascular treatments are successfully performed.

Time frame: 30 days

Incidence of major adverse events.

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.

Time frame: 1month, 3 months,6 months, 12 months ,24 months

Adverser events related to insufficient lower limb blood supply.

Major amputation, acute re-occlusion, subacute re-occlusion and chronic re-occlusion.

Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

CD-TLR

CD-TLR was deﬁned as any reintervention within the target lesion(s) because of recurrent symptoms.

Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months

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.

Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Health economics evaluation

All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.