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Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

Study acronym: STOP
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Active, Not Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Oct 1, 2026 to Oct 1, 2027
    • Start date: Dec 1, 2023 to Jun 18, 2024
    • Study sites: 1 to 2
    • Study completion date: Oct 1, 2036 to Oct 1, 2037
  2. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 1, 2023 to Dec 1, 2023
    v3
  3. Start date: Aug 1, 2023 to Oct 1, 2023
    • Primary completion date: Sep 1, 2026 to Oct 1, 2026
    • Study completion date: Sep 1, 2036 to Oct 1, 2036
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Josep Rodes-Cabau
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Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.
Trial Details
NCT Number NCT05907694
Lead Sponsor Josep Rodes-Cabau
Conditions
(from sponsor)		 Patent Foramen Ovale, Cryptogenic Stroke, Older Patients, Medical Treatment, Recurrent Stroke
Related terms Foramen Ovale, Patent, Ischemic Stroke, Stroke
Enrollment 714 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov