Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure (STOP)

March 23, 2026 updated by: Josep Rodes-Cabau

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

714

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Active, not recruiting
        • IUCPQ-UL
      • Québec, Quebec, Canada, G2E4G9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cryptogenic stroke
  • Age >60 years
  • Right-to-left shunt as evaluated by echocardiography (TEE).

Exclusion Criteria:

-≤60 year-old

  • Lacunar (small vessel) stroke.
  • Permanent or paroxysmal atrial fibrillation/flutter (clinically apparent or detected by continuous ECG monitoring).
  • Need for chronic anticoagulation therapy.
  • Any contraindication for antiplatelet therapy (aspirin, clopidogrel, ticagrelor).
  • Presence of extracranial or intracranial atherosclerosis causing ≥50% luminal --stenosis in arteries supplying the area of ischemia.
  • Presence of complex atheroma plaques at the ascending aorta-aortic arch (≥4-mm-thick, ulcerated or containing mobile thrombi) as evaluated by TEE.
  • Presence of intracardiac thrombus as evaluated by TEE.
  • Uncontrolled hypertension (systemic pressure values >160/90 mmHg despite optimal medical treatment).
  • History of myocardial infarction or coronary intervention. (percutaneous coronary intervention, coronary artery bypass graft).
  • History of prior valve surgery or transcatheter valve repair.
  • Presence of deep venous thrombosis at the time of index stroke as evaluated by Doppler ultrasonography.
  • Left ventricular ejection fraction <50% as evaluated by TTE.
  • Significant (moderate or severe) valvular disease as evaluated by echocardiography.
  • History of congestive heart failure.
  • Severe chronic kidney dysfunction defined an estimated glomerular filtration rate <30 ml/min/m2 or need for dialysis.
  • Isolated ASD or ASD associated with PFO but with a hemodynamically significant left-to-right shunt requiring closure.
  • Other specific cause of stroke identified (eg, arteritis, dissection, migraine/vasospasm, and drug abuse).
  • Prior surgical or endovascular treatments of PFO or ASD.
  • Rheumatic heart disease.
  • Left atrial enlargement defined as a left atrial diameter >41 mm in men and ≥39 mm in women.
  • Presence of high burden of premature atrial contractions (>500 per 24 hrs) as evaluated by continuous ECG monitoring.
  • Follow-up impossible or expected poor compliance.
  • Active cancer.
  • Presence of an inferior vena cava filter.
  • Severe pulmonary artery hypertension (systolic pulmonary pressure >60 mmHg).
  • Functional dependency as measured by a modified Rankin Scale score >3 (unable to attend to own bodily needs without assistance and unable to walk unassisted).
  • Any medical condition determining a life expectancy <2 years.
  • Participation in another randomized study.
  • Failure to provide signed informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transcatheter PFO closure + optimal medical treatment
Patients will undergoes transcatheter PFO closure (+ optimal 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.
Procedure: Transcatheter 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.

Drug: Optimal 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.
Experimental: Optimal 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.
Drug: Optimal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of ischemic events
Time Frame: 12 months
New ischemic non-lacunar stroke events
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of stroke events
Time Frame: 12 months
All new non-lacunar stroke events
12 months
Rate of mortality
Time Frame: 10 year follow-up
All cause mortality
10 year follow-up
Rate of cardiovascular mortality
Time Frame: 10 year follow-up
Cardiovascular death
10 year follow-up
Incidence of cerebral hemorrhage
Time Frame: 10 year follow-up
Cerebral bleeding
10 year follow-up
Rate of new-onset atrial fibrillation
Time Frame: 10 year follow-up
All new onset atrial fibrillation episodes
10 year follow-up
Rate of bleeding
Time Frame: 10 year follow-up
Major/life-threatening bleeding
10 year follow-up
Health-related quality of life
Time Frame: 10 year follow-up
Evaluated by the EQ-5D-5L questionnaire
10 year follow-up
Neurocognitive assessment
Time Frame: 10 year follow-up
Evaluated by the MoCA questionnaire
10 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Josep Rodes-Cabau

Investigators

  • Principal Investigator: IUCPQ Rodes-Cabau, MD, PhD, Fondation IUCPQ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2037

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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