Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure — STOP  

Patent Foramen Ovale Clinical Trial

Official title: Medical Treatment With or Without Transcatheter Patent Foramen Ovale CloSure for Older Patients With CrypTogenic StrOke and Patent Foramen Ovale. The STOP Trial

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Background and importance Consistent with studies performed in younger patient cohorts, older patients suffering a cryptogenic stroke exhibit a much higher prevalence of patent foramen ovale (PFO) compared to their stroke of known origin counterparts. Several studies have provided promising preliminary data regarding PFO closure in older patients with cryptogenic stroke, with very low stroke recurrence rates at mid- to long-term follow-up. Several randomized trials have shown the beneficial effects of PFO closure vs. medical treatment in patients younger than 60 years with cryptogenic stroke and PFO. Current observational data suggest similar or even more marked effects on stroke recurrence prevention of PFO closure in older patients and would support the design of a randomized trial to provide definite evidence in this field. Therefore, the objective of the present study is to evaluate the efficacy of transcatheter PFO closure for preventing recurrent ischemic stroke (nonlacunar) events in patients >60 years diagnosed with a cryptogenic stroke and PFO. ;

Related Conditions & MeSH terms

• Cryptogenic Stroke
• Foramen Ovale, Patent
• Ischemic Stroke
• Medical Treatment
• Older Patients
• Patent Foramen Ovale
• Stroke

• NCT number: NCT05907694
• Study type: Interventional
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2023
• Completion date: October 1, 2036