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SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters

Study acronym: SIROOP
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment target: 1000 to 2000
    • Site details revised
    • Collaborators expanded, about 3 words
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Primary completion date: Jul 31, 2022 to Dec 31, 2026v2 Show 4 more changesShow less
    • Primary endpoint revised
    • Study completion date: Dec 31, 2026 to Dec 31, 2031
    • Start date changed from estimate of Aug 1, 2021 to Jun 1, 2021
    • Secondary endpoints revised (26)
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.
Trial Details
NCT Number NCT04988685
Lead Sponsor Luzerner Kantonsspital
Collaborators: University Hospital, Geneva
Conditions
(from sponsor)		 Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Coronary Arteriosclerosis, Coronary Artery Calcification, Stable Chronic Angina, Angina Pectoris, Angina, Stable +2 more
Related terms Angina Pectoris, Angina, Stable, Angina, Unstable, Coronary Artery Disease, Coronary Disease, Coronary Restenosis
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov