RecruitingNot ApplicableNCT05907694

Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

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

Sponsor

Josep Rodes-Cabau

Enrollment

714 participants

Start Date

Jun 18, 2024

Study Type

INTERVENTIONAL

Conditions

Patent foramen ovale Cryptogenic Stroke Older Patients Medical Treatment Recurrent Stroke

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Optimal medical treatment and a procedure called Transcatheter PFO closure for people with cryptogenic stroke, medical treatment, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURETranscatheter PFO closure

Transcatheter PFO closure procedure will be performed according to the standards and experience of each participating center. Any approved PFO occluder device will be allowed in the study. Patients will also receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

DRUGOptimal medical treatment

Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Locations(2)

IUCPQ-UL

Québec, Quebec, Canada

IUCPQ

Québec, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05907694

Related Trials

Plaque Characteristics Predict Recurrent Stroke in MCA Stroke Patients

NCT064042421 location

Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study

NCT071724645 locations

Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)

NCT077241711 location

Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial

NCT0494874918 locations

Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS Study

NCT076989511 location