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NCT Number: NCT04966767

Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease

This is a prospective, multicenter, real-world, registry study, which aims to observe the intermediate and long-term efficacy of different endovascular treatments for TASC C&D aortoiliac occlusive disease.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

Currently, the optimal therapy for TASC C and D type aortic occlusive disease is still controversial. The evidence comes from several singe-center studies with small sample size. In addition, the long-term efficacy of stent implantation and drug coated device in aortic occlusive disease remains unclear, which might be affected by the type of stent and calcification extent. Thus, this study aims to observe the intermediate and long-term efficacy of different endovascular treatments for TASC C&D aortoiliac occlusive disease in multiple centers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rutherford classification of 3-6
  • Willing to comply with all follow-up evaluations at the specified times
  • Target lesion(s) located within the native infrarenal abdominal aorta and/or common iliac artery and/or external iliac artery
  • Evidence of ≥ 50% stenosis, restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s), or arterial thrombosis underwent PMT or CDT
  • Provides written informed consent

Exclusion criteria

  • Contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, or any other drug used during the study
  • Known hypersensitivity to contrast material that cannot be adequately pretreated
  • Bleeding diathesis or coagulopathy, known hypercoagulable condition or refuses blood transfusion
  • Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures
  • Life expectancy less than 24 months
  • Current participation in an investigational drug or other device study
  • Severe comorbid conditions
  • Myocardial infarction or stroke within 3 months prior to enrollment

Treatment and study plan

Primary outcomes

  1. Free from clinically-drived target lesion reintervention

    Time frame: 5 years

    TLR was defined as a reintervention performed for >50% diameter stenosis or in the target lesion after documentation of recurrent clinical symptoms following the index procedure or bailout stenting during the index procedure. Freedom form 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 outcomes

  1. Technique success rate

    Time frame: 30 days

    Successfully revascularize the target vessel. The residual stenosis is <30% and there is no acute thrombosis occurred in the target vessel within 30 days post-operation. The Technical success rate was defined as the rate of the number of patients who receive the treatment as intended verse the number of the patients enrolled.

  2. Perioperative adverse events

    Time frame: 30 days

    Perioperative 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.

  3. Primary patency rate

    Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

    The primary patency rate was defined as the percentage of stent patency examined by ultrasonograpy or computed tomography angiography examination of lower limb arteries during follow-up.

  4. Incidence of adverse blood supply events

    Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

    Incidence of adverse blood supply events include anyone of the following: acute or chronic occlusion of target lower extremity, major or minor amputation of a vascular etiology

  5. Vascular quality of life questionnaire(VascuQol)

    Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

    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.

  6. Total Cost of treatment

    Time frame: 3 years, 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenyu Shi, MD, PhD

CONTACT

[email protected]

0021 13564690539

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Chengdu University of Traditional Chinese Medicine
  • First Affiliated Hospital of Zhejiang University
  • First People's Hospital of Hangzhou
  • Huashan Hospital
  • Qingdao Hiser Medical Group
  • RenJi Hospital
  • Second Affiliated Hospital of Soochow University
  • Xuanwu Hospital, Beijing

Registry information

Official study title

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

Acronym: ALLIANCE

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 19, 2021
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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