Comparing Cocoon vs Amplatzer PFO Occluders in Adults After Stroke or TIA
Official title: Randomised Controlled Trial Comparing the Safety and EfficAcy of the Cocoon PFO Occluder Versus Amplatzer PFO ClosurE Device for Percutaneous Closure of Patent Foramen Ovale in Patients With a History of Stroke or Transient Ischemic Attack A Non-Profit, Single-blind, Investigator Driven Trial
Run by Sahajanand Medical Technologies Limited · NCT07380490 · Data updated 2026-11-12
This trial tests whether the Cocoon PFO Occluder works as well as the Amplatzer PFO Occluder in adults who had a cryptogenic stroke or TIA and have a PFO requiring closure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 1260 (estimated) |
| Sponsor | Sahajanand Medical Technologies Limited Industry-sponsored |
| Locations | 1 site (Bad Oeynhausen, North Rhine-Westphalia (Nordrhein-Westfalen)) |
| Status | Recruiting |
| Started | July 24, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07380490 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 64 with a PFO and a history of cryptogenic embolic stroke or TIA within the past year, suitable for transcatheter closure.
✕Probably not a fit
Patients without a PFO or without a history of cryptogenic stroke/TIA, or those with contraindications to transcatheter closure, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, randomized study compares two devices used to close a patent foramen ovale in adults who recently experienced a cryptogenic stroke or TIA. Participants are randomized 3:1 to receive the Cocoon PFO Occluder (experimental) or an Amplatzer PFO occluder (control) and undergo a percutaneous closure procedure soon after enrollment. The primary goal is to determine non-inferiority of the Cocoon device based on a composite safety and efficacy outcome at 12 months. The trial is investigator-driven, non-profit, and aims to enroll up to 1260 subjects across European centers. Follow-up and detailed endpoints beyond the primary composite are not fully described in the provided material.
Why it matters
Potential benefit: If successful, the Cocoon device could provide a safe and effective alternative for closing PFOs in patients with recent cryptogenic stroke or TIA.
How similar studies have gone: Previous PFO closure device studies have shown benefit with various devices; this trial examines non-inferiority between two approaches rather than a novel therapy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with \>18 years of age and \<65 years of age, regardless of gender * Patients with normal or aneurysm type PFO confirmed by imaging examination \[Transthoracic Echocardiography (TTE)/ Transesophageal Echocardiography (TOE) or Intracardiac Echocardiography\], and who exhibit spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver. * Patients with history of cryptogenic embolic stroke or transient ischemic attack in the previous 12 months \[stroke is defined as acute focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT findings of a new, neuroanatomically relevant, cerebral infarct. Transient Ischemic Attack is defined as acute focal neurological deficit (defined as focal motor deficit, aphasia, difficulty walking, hemisensory deficit, amaurosis fugax, blindness, or focal visual deficit) presumed due to focal ischemia, lasting between 5 minutes and 24 hours, that is not associated with MR or CT findings of a new cerebral infarct\]. The diagnosis of cryptogenic embolic stroke or TIA has to be confirmed by a neurologist. * The size of PFO must be amenable to selection of a Cocoon PFO Occluder or Amplatzer PFO closure device. * Patients are informed of the nature of the trial and agree to all requirements for participation in the trial, signed the informed consent form, and agreed to complete the follow-up and follow-up examination Exclusion Criteria: * Patients who have definite causes of stroke or transient ischemic attack unrelated to the PFO * RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt * Patients with atrial fibrillation/atrial flutter (chronic or intermittent) Intracardiac thrombus or tumor * Patients with mitral or aortic valve stenosis or severe regurgitation * Mitral or aortic valve vegetation or prosthesis * Active endocarditis or other untreated infectious diseases * Dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy * Left ventricular ejection fraction (LVEF) \<35% * Left ventricular aneurysm or akinesis Myocardial infarction or unstable angina pectoris within 12 months * Previous intracardiac surgery or percutaneous PFO-closure * Atherosclerosis or arteriopathy of intra- or extracranial vessels with \>50% diameter stenosis in the artery supplying the infarcted territory. * Patients with non-embolic cryptogenic stroke (for example lacunar stroke) or with other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding \>4 mm into the lumen), large artery atherosclerotic disease, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection * Glomerular filtration rate \< 30 ml/min/1.73 m2 or with any history of renal dialysis or renal transplantation * Severe liver function impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal value) * Severe pulmonary disease including pulmonary hypertension (clinical diagnosis) * Uncontrollable hypertension or diabetes mellitus * Contraindications to anticoagulants or antiplatelet drugs, either before or after the PFO closure procedure * Active or planned (within 12 months) pregnancy, or lactating female patients * Patients with hypercoagulable states * Patients diagnosed with a neurological disease that causes progressive neurological dysfunction * Malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months * Anatomy in which the device would interfere with intracardiac or vascular structures * Psychiatric conditions that may interfere with medical compliance and compliance with follow-up * Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint yet * Patient with any medical condition that would make him/her inappropriate for treatment as per the current IFU of respective devices or in the opinion of the Investigator * Inability to obtain Informed Consent from patient or legally authorized representatives * Stroke with poor outcome at time of enrollment (Modified Rankin score \>3) * Subjects who will not be available for follow up for the duration of the trial
Where it's running
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Heart and Diabetes Center NRW (HDZ NRW), Clinic for General and Interventional Cardiology/Angiology
Bad Oeynhausen, North Rhine-Westphalia (Nordrhein-Westfalen), Germany Recruiting
Study contacts
- Principal investigator: Giuseppe Tarantini, MD, PhD, FESC — University of Padova
- Study coordinator: Daniela Ramaccini, PhD, PharmaD
- Email: d.ramaccini@endocorelab.org
- Phone: +39 3534390426
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.