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A Study of Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon

Study acronym: PROMISING
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 5, 2024 (before its estimated February 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1200 to confirmed 2000
    • Site details revised at 9 of 9 sites
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Study sites: 1 to 9v3
  4. Study description expanded, about 1 wordv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. However, these studies have been carefully designed, and most of them have excluded long-length lesions and severely calcified lesions. In addition to being used alone in the real word, drug-coated balloons (DCB) are also used in combination with stents or debulking devices, but in these randomized controlled studies (RCT) they are only compared with standard percutaneous transluminal angioplasty (PTA). Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB.
Trial Details
NCT Number NCT04826705
Lead Sponsor Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Collaborators: RenJi Hospital, Zhejiang University, Xuanwu Hospital, Beijing, First People's Hospital of Hangzhou, Second Affiliated Hospital of Suzhou University, Qingdao University, Chengdu University of Traditional Chinese Medicine
Conditions
(from sponsor)		 Drug-coated Balloon, Femoropopliteal Artery Occlusion, Angioplasty
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov