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PFO Occluder
PFO Closure Devices for Stroke Prevention (OCCLUFLEX Trial)
N/A
Recruiting
Research Sponsored by Occlutech International AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with a PFO and cryptogenic stroke
Cryptogenic stroke defined as a stroke of unknown cause
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to twelve months, annually thereafter.
Awards & highlights
OCCLUFLEX Trial Summary
This trial is testing three devices for closing a PFO, a hole in the heart, to see which is best at preventing recurrent embolic stroke with the fewest serious side effects.
Who is the study for?
This trial is for adults aged 18 and over who've had a stroke of unknown cause (cryptogenic) linked to a heart condition called Patent Foramen Ovale (PFO). Participants must be able to stop anticoagulation meds, have a life expectancy over 2 years, and not have other conditions causing strokes or serious heart issues.Check my eligibility
What is being tested?
The study compares the Occlutech Flex II PFO Occluder with standard devices like the AMPLATZER™ PFO Occluder in preventing strokes by closing the PFO. It looks at how well they work and their safety by tracking Serious Adverse Events related to them.See study design
What are the potential side effects?
Potential side effects from using these occlusion devices may include discomfort at the implant site, bleeding, blood vessel damage, irregular heartbeat, or allergic reactions to device materials.
OCCLUFLEX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a hole in my heart and had a stroke with an unknown cause.
Select...
I had a stroke, but doctors don't know why.
Select...
I had a stroke with symptoms lasting over 24 hours or had imaging showing a new stroke.
OCCLUFLEX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ twelve months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~twelve months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effective Closure Rate of PFO
Secondary outcome measures
Non-Fatal Recurrent Stroke
Other outcome measures
Safety: Device and Procedure Related Serious Adverse Events
OCCLUFLEX Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational PFO Closure DeviceExperimental Treatment1 Intervention
PFO closure with the study Occlutech Flex II PFO device.
Group II: Standard of Care PFO Closure DeviceActive Control1 Intervention
PFO closure with either of the standard of care PFO occlusion devices; Amplatzer PFO Occluder or the Gore Cardioform PFO Occluder.
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Who is running the clinical trial?
Occlutech International ABLead Sponsor
15 Previous Clinical Trials
3,541 Total Patients Enrolled
David Thaler, MD, PhD, FAHAStudy ChairTufts Medical Center and Tufts University School of Medicine
Steven Yakubov, MD, FACC, MSCAIStudy ChairOhioHealth Heart & Vascular
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 18 years old but not older than 50.I have a severe heart valve problem.You have growths or artificial valves in your heart.I cannot take aspirin or clopidogrel due to health reasons.You have plaques in your aortic arch that stick out more than 4 millimeters into the blood vessel.Your heart is not pumping enough blood.I need help with my daily activities due to a stroke.I do not have heart conditions like atrial fibrillation or heart aneurysms.I have not had a heart attack or unstable chest pain in the last 6 months.I had an arterial dissection.My high blood pressure or diabetes is not controlled by medication.I cannot stop taking my blood thinning medication.I had a small stroke likely caused by a blockage in a tiny blood vessel and have high blood pressure, diabetes, am over 50, or have specific brain scan results.I have a blocked artery in my brain that caused a stroke.I have a hole in my heart and had a stroke with an unknown cause.You have a condition called a patent foramen ovale (PFO) that allows bubbles to pass from the right side of the heart to the left side.I had a stroke, but doctors don't know why.I had a stroke with symptoms lasting over 24 hours or had imaging showing a new stroke.The device would not interfere with my heart or blood vessels.I have a condition that causes my blood to clot more easily.I have a condition that causes abnormal blood flow in my heart.You are not expected to live for more than 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational PFO Closure Device
- Group 2: Standard of Care PFO Closure Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there openings for individuals to join this experimentation?
"Sadly, the clinical trial is no longer recruiting. Initially posted on April 30th 2022 and last updated on October 10th 2022, this medical research project is not actively seeking applicants. However, there are more than a thousand other trials presently enrolling patients."
Answered by AI
How many facilities are currently involved in the management of this research endeavor?
"Numerous medical centres are currently enrolling patients in this trial, with Sentara Health Research Center (Norfolk), Vanderbilt Medical Center (Nashville) and Cardiovascular Institute of the South (Houma) among them."
Answered by AI
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