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Outcome of Endovascular Therapies in Chronic Femoropopliteal Occlusive Disease With Severe Calcification

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04716361
Collaborator
(none)
600
Enrollment
1
Location
48.7
Anticipated Duration (Months)
12.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a prospective, multicenter, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in chronic femoropopliteal occlusive disease with severe calcification. It is estimated that 400 subjects diagnosed with chronic femoropopliteal occlusive disease with severe calcification and receive endovascular treatments will be enrolled in eight centers nationwide from January 2021 to December 2022. All the subjects will be under follow-up for two years. There is no restriction on the endovascular techniques. The primary outcomes include the technical success rate of each endovascular techniques and the reintervention rate driven by lesions' clinical symptoms.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Arteriosclerosis obliterans (ASO) is a common disease in middle-aged and elderly people, which affects up to 30% people who are over 70 years in the general population. Its symptoms include claudication, rest pain and ischemic tissue loss depending on its severity. Nowadays, endovascular treatments have become the first-line therapy. If ASO is combined with severe calcification, the treatment will be much more challenging. The efficacy of plain old balloon angioplasty is limited. New devices including drug-coated balloon, intravascular Lithotripsy, directional atherectomy, Supera stent and drug-eluting stent offer another chance and better prognosis. The data of these new devices, however, are mainly from low quality evidence. Therefore, we start this prospective, multicenter, real world, observational study, providing new data on the safety, efficacy and health economics evaluation of endovascular treatments for endovascular therapies in chronic femoropopliteal occlusive disease with severe calcification.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical and Economic Outcome of Endovascular Therapies in Chronic Femoropopliteal Occlusive Disease With Severe Calcification (The Evolution Study): a Prospective, Multi-center，Observational Study
    Actual Study Start Date :
    Dec 10, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Technical success rate [1 week]

      Successfully revascularize the target vessel. The residual stenosis is <30% and there is no acute thrombosis occurred in the target vessel within 1 week post-operation.

    2. The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional [1 month]

      Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.

    3. The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional [6 months]

      Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.

    4. The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional [12 months]

      Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.

    5. The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional [18 months]

      Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.

    6. The clinically driven target lesion revascularization(CD-TLR) rate at post-interventional [24 months]

      Any reintervention within the target lesion due to symptoms or drop of ≥20% ABI compared to baseline.

    Secondary Outcome Measures

    1. Vascular quality of life questionnaire(VascuQol) [1 month,6 months,12 months,18 months and 24 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.

    2. Incidence of severe adverse events [1 month,6 months,12 months,18 months and 24 months]

      Severe adverse events include anyone of the following: Myocardial infarction, ischemic stroke, cardiovascular mortality, acute limb ischemia, and major amputation of a vascular etiology.

    3. Patency of the target vessel [Patency of the target vessel. [ Time Frame: 1 month,6 months,12 months,18 months and 24 months]

      The patency is assessed by the vascular ultrasound.

    4. Health economics evaluation [24 months]

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

    5. Wound, Ischemia, and foot infection(WIFI) classification system [1 month,6 months,12 months,18 months and 24 months]

      The Wound, Ischemia, and foot Infection (WIfI) classification system is a composite outcome measure encompassing demographic changes and expanding techniques of revascularization to perform meaningful analyses of outcomes in the treatment of the threatened limb, including wound, ischemia and foot infection. Each index was evaluated by very low, low, moderate and high, the very low represents no risk, the high reveals high risk of amputation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Rutherford stages 2-6

    2. The target vessel (femoral and/or popliteal artery) has at least ≥90% stenosis or occlusion with the moderate to severe calcification (defined as >5 cm continuous calcification)

    3. For patients with both lower limbs to be treated, the side with severer calcification is selected. If the calcification is similar in the two sides, the first one to be treated is selected.

    4. At least one outflow artery (which is patent in > 1/3 length) in the calf connects the popliteal artery.

    5. Patients who failed the first treatment because the guide wire could not pass through the lesion can still be selected if the second endovascular treatment succeeds.

    6. There is no restriction on the types of endovascular techniques and devices.

    Exclusion Criteria:
    Exclusion Criteria:

    1. Life expectation less than one year

    2. There is several infection and/or major tissue loss in the leg. Even if after revascularization, patient still need amputation.

    3. The quality of patients' life cannot be assessed by vascular quality of life questionnaire due to difficulties in communication.

    4. Chronic femoropopliteal occlusive disease without calcification.

    5. Patients with acute arterial thrombosis.

    6. Limbs that have been treated with the femoral and popliteal artery bypass surgery.

    7. Pregnant women

    8. Allergic to contrast medium

    9. Participating in other drug or device studies currently.

    10. Systematic infection and/or coagulation disorders 14 days before the enrollment.

    11. Patients have severe systematic disease that cannot be controlled currently such as severe heart, lung disease, live function disorder, end stage cancer, etc

    12. Stroke, myocardial infarction, bleeding in the past 6 month

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affliated Hospital, Zhejiang University, School of Medicine Hangzhou Zhejiang China 310000

    Sponsors and Collaborators

    • First Affiliated Hospital of Zhejiang University

    Investigators

    • Principal Investigator: Ziheng Wu, M.D., First Affiliated Hospital of Zhejiang University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    First Affiliated Hospital of Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04716361
    Other Study ID Numbers:
    • IIT20200011B
    First Posted:
    Jan 20, 2021
    Last Update Posted:
    Dec 6, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by First Affiliated Hospital of Zhejiang University
    Peripheral artery disease
    Calcification
    Endovascular treatment
    Additional relevant MeSH terms:
    Calcinosis

    Study Results

    No Results Posted as of Dec 6, 2021