An interventional study of PFO closure with GORE® CARDIOFORM Septal Occluder in Stroke and PFO - Patent Foramen Ovale, sponsored by W.L.Gore & Associates. Recruiting at 45 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by W.L.Gore & Associates · Not applicable, Interventional, and Prevention
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Among 1,994 studies in Stroke with a site in United States — 395 open to participants now, 492 under way, 17 of them phase 3. Stroke · United States.
Among the 1,994 studies in Stroke with a site in United States, this one is the 122nd largest by planned enrollment of the 1,620 interventional ones that give a count, is one of 117 that started in 2019, is one of 1,124 with no phase, reaches primary completion later than 390 of the 490 other live ones, and was the 1,125th registered.
8,268 studies on the registry are indexed under Stroke; 2,062 are open to participants now.
Browse Stroke studies →395 of the 1,994 studies in Stroke with a site in United States are open now. Recruiting first, the newest first:
University of Utah · Sites in United States
Ages 40–85
Carle Foundation Hospital · Sites in United States
Ages 18+
Weill Medical College of Cornell University · Sites in United States
Ages 18–79
Neuralink Corp · Sites in United States
Ages 18+
Casa Colina Hospital and Centers for Healthcare · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,418 Stroke studies recruiting now, 696 (49%) set no upper age limit and 282 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,994 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 173 · Phase 2 235 · Phase 3 126 · Phase 4 43
First in 1980; this study’s year is marked. 117 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 636 is above the median of 49 across 6,036 interventional studies indexed under Stroke.
Median enrollment 40 across the 1,620 interventional studies, 153 across the 363 observational. Of the 1,328 that completed or were terminated, 563 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
295 of 1,994 have an industry lead sponsor. The 10 most frequent:
W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
W.L.Gore & Associates has 6 studies filed under Stroke — fewer than ten, so there is no comparison to draw.
164 of the studies in Stroke with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05065216Phase 3DiaMedica Therapeutics IncTreatment of Acute Ischemic Stroke (ReMEDy2 Trial) | 2026-12 |
| NCT03223220Phase 3Lower Merion Neurology Research FoundationQuelling of Excitotoxicity in Acute Stroke With Ketamine | 2026-12-31 |
| NCT05047172Phase 3University of FloridaComparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis | 2027-01-31 |
| NCT05691244Phase 3Pharmazz, Inc.Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | 2027-09 |
| NCT05997914University of Massachusetts, WorcesterStorytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation | 2026-11 |
Add all 164 to your calendar (.ics) → With an account.
Among the 1,994 studies in Stroke with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.
A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single Arm Commercially available GORE® CARDIOFORM Septal Occluder
Device: PFO closure with GORE® CARDIOFORM Septal Occluder
PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke
Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome)
Proportion of subjects with recurrent ischemic stroke post study device implant
Time frame: 24 months
Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint)
Device- or procedure- related serious adverse events post study device implant
Time frame: 30 days
Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment
Complete PFO closure or a trivial or small residual shunt Proportion of subjects with complete PFO closure or a trivial or small residual shunt
Time frame: 12 months
Clinically Significant New Atrial Arrhythmia
Any new atrial fibrillation or flutter
Time frame: 60 months
Clinically Significant New Atrial Arrhythmia by Age
Any new atrial fibrillation or flutter in patients greater and less than 60 years of age
Time frame: 60 months
Residual Shunt Characterization via assessment of shunt in patients by Echo
Assessment of shunt in patients by Echo
Time frame: 24 months
Technical Success defined as successful delivery and retention of the GSO device based on physician reporting
Successful delivery and retention of the GSO device
Time frame: Index procedure
Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs)
Successful implantation of the GSO device with no reported in-hospital SAEs
Time frame: Enrollment through discharge, approximately 1 day
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Plan to share: No
No publications or documents are linked to this record.
Started Jul 2019 (actual). Primary completion is estimated for Oct 2028, 111 months after the start.
Of 144 industry-sponsored interventional studies with no phase under Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 111 months is above that.
Counting every sponsor, half of 3,261 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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