Status:

RECRUITING

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.

Lead Sponsor:

Shanghai Zhongshan Hospital

Collaborating Sponsors:

RenJi Hospital

First Affiliated Hospital of Zhejiang University

Conditions:

Peripheral Arterial Disease

Eligibility:

All Genders

18-80 years

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 occlusiv...

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 art...

Eligibility Criteria

Inclusion

  • Rutherford grades 3-6.
  • Follow the follow-up arrangement.
  • Age: 18-80 years old.
  • The target lesions were in the lower abdominal aorta and/or the common iliac artery and/or the external iliac artery.
  • 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.
  • Signed informed consent.

Exclusion

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

Key Trial Info

Start Date :

April 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 1 2032

Estimated Enrollment :

800 Patients enrolled

Trial Details

Trial ID

NCT05391815

Start Date

April 1 2021

End Date

June 1 2032

Last Update

May 26 2022

Active Locations (1)

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Zhongshan Hospital, Fudan University

Shanghai, China