Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

NCT05907694 | Recruiting DMC

• 1 other identifier: STOP
• Study Type: interventional
• Target: 714
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Recurrent Stroke; Patent Foramen Ovale; Cryptogenic Stroke; Older Patients; Medical Treatment

Outcome Measures

Primary Outcomes (1)

• Rate of ischemic events

  New ischemic non-lacunar stroke events

  12 months

Secondary Outcomes (8)

• Rate of stroke events

  12 months

• Rate of mortality

  10 year follow-up

• Rate of cardiovascular mortality

  10 year follow-up

• Incidence of cerebral hemorrhage

  10 year follow-up

• Rate of new-onset atrial fibrillation

  10 year follow-up

Study Arms (2)

transcatheter PFO closure + optimal medical treatment

EXPERIMENTAL

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; Drug: Optimal medical treatment

Optimal medical treatment

EXPERIMENTAL

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

Interventions

Optimal medical treatment DRUG

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.

Optimal medical treatment; transcatheter PFO closure + optimal medical treatment

Transcatheter PFO closure PROCEDURE

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.

transcatheter PFO closure + optimal medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ≤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.

Sponsors & Collaborators

• Josep Rodes-Cabau: lead

Study Sites (2)

IUCPQ-UL

Québec, Quebec, G1V 4G5, Canada

ACTIVE NOT RECRUITING

IUCPQ

Québec, Quebec, G2E4G9, Canada

RECRUITING

Related Publications (37)

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MeSH Terms

Conditions

Foramen Ovale, Patent; Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• IUCPQ Rodes-Cabau, MD, PhD

  Fondation IUCPQ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josep Rodes-Cabau, MD, PhD

CONTACT

4186568711; josep.rodes@criucpq.ulaval.ca

Melanie Cote, MSc

CONTACT

4186568711; melanie.cote@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial comparing transcatheter PFO closure + medical treatment vs. medical treatment alone.

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: June 18, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2037
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)