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.

May 23, 2022 updated by: Shanghai Zhongshan Hospital

Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease: a Prospective, Multicenter, Real-world, Registry Study

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
          • Zhenyu Shi, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The TASC C&D Aorta-iliac occlusion patients.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from clinically-driven TLR
Time Frame: 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.
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of major adverse events.
Time Frame: 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.
1month, 3 months,6 months, 12 months ,24 months
Technical success rate
Time Frame: 30 days
We defined the technical success rate as the rate of patients in whom the endovascular treatments are successfully performed.
30 days
Adverser events related to insufficient lower limb blood supply.
Time Frame: 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.
1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
CD-TLR
Time Frame: 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.
1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Vascular quality of life questionnaire(VascuQol)
Time Frame: 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.
1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Health economics evaluation
Time Frame: 60 months
All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

First People's Hospital of Hangzhou
RenJi Hospital
Huashan Hospital
Chengdu University of Traditional Chinese Medicine
Xuanwu Hospital, Beijing
First Affiliated Hospital of Zhejiang University
Second Affiliated Hospital of Soochow University
Qingdao Hiser Medical Group
Liyuan Hospital of Tongji Medical College of Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

June 1, 2027

Study Completion (Anticipated)

June 1, 2032

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The ALLIANCE Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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