Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGiuseppe Tarantini
About this trial
This study is a prospective, multicenter, randomized, controlled, single-blind, investigator-driven, non-profit clinical trial designed to compare the safety and efficacy of the Cocoon PFO Occluder with the Amplatzer PFO Occluder family in patients requiring percutaneous closure of a patent foramen ovale (PFO). Eligible participants are adults with a history of cryptogenic embolic stroke or neurologically confirmed transient ischemic attack (TIA) within the previous 12 months and a PFO suitable for transcatheter closure.
A total of up to 1260 subjects will be enrolled across multiple European centers. Participants will be randomly assigned in a 3:1 ratio to receive either the Cocoon PFO Occluder (experimental group) or an Amplatzer PFO closure device (control group). The procedure will be performed as soon as possible after randomization, preferably within 14 days and no later than 45 days.
The primary endpoint is a non-inferiority comparison of a composite outcome at 12 months, including recurrent ischemic stroke, TIA, or all-cause death. Secondary endpoints include PFO closure rate at 6 months, assessed by echocardiographic imaging, and other measures of safety, device performance, and clinical outcomes.
The study is conducted in a single-blind fashion: patients will not be informed of the device they receive unless they explicitly request this information. Any patient who chooses to be unblinded will continue to participate without affecting eligibility or follow-up, and the date of unblinding will be documented to allow appropriate sensitivity analyses.
This trial aims to provide robust comparative evidence on the clinical performance of the Cocoon PFO Occluder relative to the Amplatzer PFO Occluder to guide optimal device selection in patients with cryptogenic stroke or TIA associated with PFO.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PFO Closure procedure
DevicePercutaneous PFO closure performed according to standard clinical practice. The procedure is scheduled within 45 days after randomization and includes initiation of dual antiplatelet therapy before the intervention. Closure is performed following the Instructions for Use (IFU) of the assigned device and is guided by intracardiac echocardiography or transesophageal echocardiography. After device implantation, patients undergo routine post-procedure assessment and are instructed to follow antiplatelet therapy consistent with European clinical practice guidelines. Endocarditis prophylaxis is recommended for six months. The procedural steps are identical for both study arms; the only difference is the device implanted (Cocoon PFO Occluder or Amplatzer PFO Occluder). Participants are assigned to the two study arms using a 3:1 randomization scheme (Cocoon PFO Occluder : Amplatzer PFO Occluder).
Treatment groups
1,260 Participants
are divided into 2 treatment groupsGroup A: Cocoon PFO Occluder - experimentalExperimental treatment 1 intervention
Group B: Amplatzer PFO Occluder - ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite endpoint of recurrent ischemic stroke, TIA, or all-cause death at 12 months
A non-inferiority comparison between the Cocoon PFO Occluder and the Amplatzer PFO Occluder in terms of a composite endpoint including: 1. Recurrent ischemic stroke, defined as an acute focal neurological deficit presumed to result from focal ischemia, with symptoms lasting ≥24 hours, or \<24 hours if accompanied by MRI or CT evidence of a new, anatomically relevant cerebral infarct. 2. Transient ischemic attack (TIA), defined as an acute focal neurological deficit (e.g., focal motor deficit, aphasia, gait disturbance, hemisensory deficit, amaurosis fugax, blindness, or focal visual deficit) presumed due to focal ischemia, lasting between 5 minutes and 24 hours, and not associated with MRI or CT evidence of a new infarct. Clinical evaluation by a neurologist is required. 3. All-cause mortality.
Time frame
12 months after the procedureSecondary outcomes
1
PFO Closure Rate
Complete closure is defined as right-to-left shunt (RLS) grade 0. Effective closure is defined as RLS grade 0 or 1 on imaging (TTE as default, TOE when clinically indicated)
Time frame
6 months2
Composite of Recurrent Ischemic Stroke, TIA, or Death
Composite endpoint including recurrent ischemic stroke, TIA (neurologist-confirmed), or all-cause mortality.
Time frame
30 days and 6 months3
Neurological Death
Death attributable to neurological causes.
Time frame
30 days, 6 months, 12 months4
Cardiovascular Death
Death attributable to cardiovascular causes.
Time frame
30 days, 6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Giuseppe Tarantini
Lead sponsor
Sahajanand Medical Technologies Limited
Sponsor institution
Sahajanand Medical Technologies Limited
Collaborator
Source ClinicalTrials.gov