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出境医 / 临床实验 / The PROOF Trial - 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 (

The PROOF Trial - 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 (

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Stroke PFO - Patent Foramen Ovale Device: Occlutech PFO Occluder

Detailed Description:
This study aims to investigate stroke recurrence rates after interventional PFO closure with an Occlutech PFO Occluder in patients who have experienced at least one ischemic cryptogenic stroke attributed to patent foramen ovale (PFO) who have high risk PFO, i.e. large PFO (≥2 mm), or PFO of any size and atrial septal aneurysm (ASA).
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 863 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2026
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. To demonstrate the safety and tolerability of the Occlutech PFO occluder by assesssing the incidence of SADEs. [ Time Frame: in the 1 year following implantation. ]
  2. To demonstrate the medium-term effectiveness of the Occlutech PFO Occluder by assessing the rate of ischemic strokes. [ Time Frame: in the 5 years following implantation ]

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date July 18, 2019
First Posted Date July 23, 2019
Last Update Posted Date November 20, 2020
Actual Study Start Date October 3, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2019)
  • To demonstrate the safety and tolerability of the Occlutech PFO occluder by assesssing the incidence of SADEs. [ Time Frame: in the 1 year following implantation. ]
  • To demonstrate the medium-term effectiveness of the Occlutech PFO Occluder by assessing the rate of ischemic strokes. [ Time Frame: in the 5 years following implantation ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The PROOF Trial - 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
Official 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
Brief Summary 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.
Detailed Description This study aims to investigate stroke recurrence rates after interventional PFO closure with an Occlutech PFO Occluder in patients who have experienced at least one ischemic cryptogenic stroke attributed to patent foramen ovale (PFO) who have high risk PFO, i.e. large PFO (≥2 mm), or PFO of any size and atrial septal aneurysm (ASA).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population This study will enroll patients of either sex, aged ≥18 and ≤60 years, with at least one event of cryptogenic ischemic stroke in the last 6 months. Patients must have a high risk PFO indicated for device-assisted closure; either large PFO (≥2 mm), or PFO of any size and ASA.
Condition
  • Stroke
  • PFO - Patent Foramen Ovale
Intervention Device: Occlutech PFO Occluder
The Occlutech PFO Occluder is a medical device for transcatheter closure of PFO.
Other Name: Occlutech Figulla Flex II Occluder
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 19, 2019) 		863
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2026
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age ≥18 years and ≤60 years
  • At least one event of cryptogenic ischemic stroke in the last 6 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
  • Allergies to nickel and/or titanium and/or nickel/titanium-related material, if not medically manageable
  • Inability to achieve adequate oral anticoagulation therapy and/or platelet inhibition post intervention
  • Intolerance to contrast agents, if not medically manageable
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Gönül Sönmez Utkun +90 2124650497 clinicaltrials@occlutech.com
Listed Location Countries Canada,   Germany,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04029233
Other Study ID Numbers Occ2019_01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Occlutech International AB
Study Sponsor Occlutech International AB
Collaborators Not Provided
Investigators Not Provided
PRS Account Occlutech International AB
Verification Date November 2020

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