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The Efficacy of Endovascular Treatment in FPOD With TASC C and D Lesions

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Notable Primary endpoint(s) modified Show 6 more changesShow less
    • Trial completed
    • Final enrollment: 1518 participants (planned 1000)
    • Study completion date changed from estimate of Dec 31, 2026 to Aug 31, 2026
    • Secondary endpoints: 2 to 5
    • Collaborators: details revised at 1 of 10 entries
    • Eligibility criteria shortened, about 3 words
  2. Minor Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Start date: Jan 1, 2021 to Dec 1, 2020
    v7
  3. Minor Trial status: Recruiting to Active, Not Recruitingv6 Show 4 more changesShow less
    • Eligibility criteria shortened, about 21 words
    • Secondary endpoints: 3 to 2
    • Site details revised
    • Collaborators: 5 to 10
  4. Notable Primary completion date: Dec 31, 2023 to Dec 31, 2025v5
  5. Minor Re-verified, no change to tracked fieldsv4
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 20, 2021 to Jan 1, 2021
    • Collaborators expanded, about 29 words
    v3
  2. Minor Start date: Jan 1, 2021 to Jan 20, 2021
    • Eligibility criteria expanded, about 2 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures. The TASC D lesion ,especially with popliteal artery involved are often excluded in prospective clinical trials. Therefore, a well-designed real world study that track clinical relevant outcomes, are required to determine the optimal therapies for patients with complex femoropopliteal lesions.
Trial Details
NCT Number NCT04698304
Lead Sponsor RenJi Hospital
Collaborators: Xuanwu Hospital, Beijing, Second Affiliated Hospital of Suzhou University, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Chengdu University of Traditional Chinese Medicine, First Affiliated Hospital of Zhejiang University, Xiamen Cardiovascular Hospital, Xiamen University, Shanghai Zhongshan Hospital, Huashan Hospital, Qingdao Haici Hospital, First People's Hospital of Hangzhou
Conditions
(from sponsor)
Femoropopliteal Occlusive Disease
Enrollment 1,518 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov