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NCT Number: NCT05391815

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.

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.

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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

Primary location

Zhongshan Hospital, Fudan University

Shanghai, China

Location status: Recruiting

Location contact

Zhenyu Shi, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

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

Zhenyu Shi, MD,PhD

CONTACT

[email protected]

+86021-64041990

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
  • Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • 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

Important dates

Study start
2021
Primary completion
2027
Study completion
2032
First posted
May 26, 2022
Registry last updated
May 26, 2022

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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