Stroke Clinical Trial
— PROOFOfficial title:
Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO
Verified date | October 2023 |
Source | Occlutech International AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
Status | Active, not recruiting |
Enrollment | 570 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age =18 years and =65 years - At least one event of cryptogenic ischemic stroke in the last 12 months - Presence of a PFO indicated for device-assisted closure (in compliance with the Instruction for Use) confirmed by common practice procedures - A large PFO (maximum separation of the septum primum from the secundum) of =2 mm confirmed by common practice procedures, or an ASA defined by common practice procedures as septum primum excursion of =10 mm - Life expectancy of at least 1 year - Ability to speak fluently and to understand the language in which the study is being conducted - Written, informed consent by the patient for participation in the study and agreement to comply with the follow-up schedule Exclusion Criteria: - Acute infection(s) - Known coagulation disorder - Arrhythmia - Atrial Tumor - Allergies to nickel and/or titanium and/or nickel/titanium-related material - Inability to achieve adequate oral anticoagulation therapy and/or platelet inhibition post intervention - Intolerance to contrast agents - Participation in another clinical investigation <30 days before intended Occlutech PFO Occluder implantation procedure (note that in line with Medical Device Reporting, registries are not considered as clinical investigations) - Contraindication to use of trans-esophageal echocardiography (TEE) and/or use of general anesthetic - Eisenmenger Syndrome - Recent pelvic venous thrombosis - Myocardial infarction or coronary artery bypass surgery within the last 30 days - Atrial thrombus - Patients whose size or condition would cause them to be a poor candidate for cardiac catheterization (e.g. too small for echocardiography imaging probe, catheter size, vasculature size, active infection, body weight <8 kg) The following exclusion criteria are at the discretion of the investigator: - Stroke of any other origin - Large artery atherosclerosis - Small vessel disease - Arterial dissection - Hypercoagulable disorder - Uncontrolled hypertension - Uncontrolled diabetes - Autoimmune disease - Evidence of drug or alcohol abuse - Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter - End-stage heart-, liver-, lung-, or kidney disease - Cardiac tumor - Endocarditis or septicemia - Severe valvular pathology - Any condition that, in the opinion of the investigator, might interfere with the implantation,might affect the patients' well-being thereafter or might interfere with the conduct of the study |
Country | Name | City | State |
---|---|---|---|
Canada | St. Paul's Hospital | Vancouver | |
France | CHU Clermont-Ferrand | Clermont-Ferrand | |
France | Institut de Cardiologie,groupe hospitalier pitié salpêtrière | Paris | |
France | New Civil Hospital | Strasbourg | |
France | CHU Rangueil | Toulouse | |
Germany | Charité Universität Berlin | Berlin | |
Germany | Herzzentrum Bremen | Bremen | |
Germany | Klinikum Coburg | Coburg | |
Germany | Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden | Dresden | |
Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
Germany | CardioVasculäres Centrum Frankfurt | Frankfurt | |
Germany | Uniklinik Freiburg | Freiburg | |
Germany | Asklepios Klinik Hamburg | Hamburg | |
Germany | Uniklinik Heidelberg | Heidelberg | |
Germany | University Jena | Jena | |
Germany | Herzzentrum der Universität zu Köln | Köln | |
Italy | Centro Cardiologico Monzino | Milan |
Lead Sponsor | Collaborator |
---|---|
Occlutech International AB |
Canada, France, Germany, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To demonstrate the safety and tolerability of the Occlutech PFO occluder by assesssing the incidence of SADEs. | in the 1 year following implantation. | ||
Primary | To demonstrate the medium-term effectiveness of the Occlutech PFO Occluder by assessing the rate of ischemic strokes. | in the 5 years following implantation |
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