Patent Foramen OvalePhase 2/3NCT00201461
Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)
A Phase 2/3 study testing STARFlex septal closure system and Best medical therapy in people with Patent Foramen Ovale and Stroke, run by NMT Medical at 1 site in United States.
Trial summary
The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patent Foramen Ovale, Stroke, Ischemic Attack, Transient
- What is being tested?
- STARFlex septal closure system and Best medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Apr 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Major Inclusion Criteria:
- Age 18-60 years inclusive.
- Positive contrast valsalva bubble study by trans-esophageal echocardiogram (TEE) for patent foramen ovale (PFO), with or without atrial septal aneurysm.
- Stroke or clinically definite TIA (contact study coordinator).
- Be able to comply with follow up over two years.
- Be competent to, or have a legal guardian competent to, provide informed consent following full disclosure of risks and benefits of both treatment arms by a study investigator.
- Venous access capable of accepting a 10F minimum vascular sheath.
- Have, or be willing to, discontinue hormonal based contraceptive use prior to enrollment and for the term of the study.
- Has cardiac anatomy based on enrollment echocardiogram that will allow for placement of the implant if randomized to the implant arm.
- Note: Additional inclusion criteria may apply. Contact study coordinator or principal investigator for details.
Post-randomization - device patients only
- The size of the PFO (measured by indentation with a soft balloon) must be amenable to selection of a STARFlex device.
Major Exclusion Criteria:
- Carotid artery stenosis > 50%.
- Intracranial stenosis > 50% appropriate to symptoms.
- Complex aortic arch atheroma with high risk features for embolism
- Aortic arch, carotid or vertebral artery dissection.
- Mitral or aortic valve stenosis, vegetation, or calcification > 5 mm mitral annular calcification (MAC) thickness.
- Active pregnancy.
- Active infections (contact study coordinator).
- Active infective endocarditis or bacteremia.
- Prosthetic heart valves in any location.
- Anterior MI within 3 months of neurological event.
- Chronic atrial fibrillation
- Thrombus in, or occluded, venous access route.
- Contraindication to heparin, aspirin, clopidogrel, or warfarin, or a known medical condition that requires continuous warfarin.
- Patient enrolled in another investigation study where clinical endpoint interference may occur.
- Permanent pacemaker or inferior vena cava (IVC) filter.
- Serum creatinine > 2.0 mg/dL
- Patients with known vasculitis or neurologic disorder.
- Baseline modified Rankin score of 3 or more.
- Hypercoagulopathies requiring long-term warfarin.
- Note: Additional exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex® Septal Closure System Versus Best Medical Therapy in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale
The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy.
- Conditions
- Patent Foramen Ovale, Stroke, Ischemic Attack, Transient
- Being tested
- STARFlex septal closure system, Best medical therapy
- Keywords
- Patent Foramen Ovale, STARFlex, CLOSURE I, Septal Closure System, Stroke, Cerebrovascular Accident, Transient Ischemic Attack, Heart Septal Defects, Atrial
- Medical subject headings
- Foramen Ovale, Patent, Stroke, Ischemic Attack, Transient, Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARFlex septal closure systemDevice
transcatheter placement of STARFlex device to close a patent foramen ovale
Best medical therapyDrug
aspirin (325 mg daily) and/or warfarin (target INR = 2.5)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Best medical therapy Receives: Drug: Best medical therapy |
| 2 | Experimental | STARFlex arm Receives: Device: STARFlex septal closure system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two (2) year incidence of stroke or Hard TIA
Measured: 2 years
All cause mortality for the first 30 days of follow up/discharge, whichever is longer
Measured: 30 days
Neurological mortality from 31 days of follow up (F/U) or longer
Measured: 31 days
Secondary outcomes (4)
Incidence of primary endpoint as a total and broken down by event type/treatment group in: stroke/TIA patients (pts) and DW-MR+ pts with symptoms < 24 hours
Measured: < 24 hrs
Incidence of primary endpoint in BMT group
Measured: 2 years
Per treatment group, incidence of relevant/notable adverse events (AEs)
Measured: 2 years
Device group: (1) Incidence of primary endpoint in pts prescribed aspirin (325 versus 81 mg) daily, (2) Incidence of relevant/notable AEs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2003
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NMT Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anthony Furlan, MD, Principal investigator, Cleveland Clinic Foundation, Cleveland, OHMark Reisman, MD, Principal investigator, Swedish Medical Center, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201461
- Sponsor's protocol ID
- G980031
- Other IDs
- CLOSURE I
- Status last verified
- Nov 2008
- First submitted
- 12 Sep 2005
- Last updated
- 30 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elmariah S, Furlan AJ, Reisman M, Burke D, Vardi M, Wimmer NJ, Ling S, Chen X, Kent DM, Massaro J, Mauri L; CLOSURE I Investigators. Predictors of recurrent events in patients with cryptogenic stroke and patent foramen ovale within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) trial. JACC Cardiovasc Interv. 2014 Aug;7(8):913-20. doi: 10.1016/j.jcin.2014.01.170.
PubMed 25147037Furlan AJ, Reisman M, Massaro J, Mauri L, Adams H, Albers GW, Felberg R, Herrmann H, Kar S, Landzberg M, Raizner A, Wechsler L; CLOSURE I Investigators. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med. 2012 Mar 15;366(11):991-9. doi: 10.1056/NEJMoa1009639.
PubMed 22417252Furlan AJ, Reisman M, Massaro J, Mauri L, Adams H, Albers GW, Felberg R, Herrmann H, Kar S, Landzberg M, Raizner A, Wechsler L; CLOSURE I Investigators. Study design of the CLOSURE I Trial: a prospective, multicenter, randomized, controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system versus best medical therapy in patients with stroke or transient ischemic attack due to presumed paradoxical embolism through a patent foramen ovale. Stroke. 2010 Dec;41(12):2872-83. doi: 10.1161/STROKEAHA.110.593376. Epub 2010 Nov 4.
PubMed 21051670
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex® Septal Closure System Versus Best Medical Therapy in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale
- ClinicalTrials.gov ID
- NCT00201461
- Acronym / sponsor ID
- G980031
- Conditions
- Patent Foramen Ovale, Stroke, Ischemic Attack, Transient
- Keywords
- Patent Foramen Ovale, STARFlex, CLOSURE I, Septal Closure System, Stroke, Cerebrovascular Accident, Transient Ischemic Attack, Heart Septal Defects, Atrial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- NMT MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Apr 2010 (estimated)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Best medical therapyBest medical therapy |
| 2 | Experimental | Device: STARFlex septal closure systemSTARFlex arm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STARFlex septal closure systemtranscatheter placement of STARFlex device to close a patent foramen ovale | Device | 2 |
| Best medical therapyaspirin (325 mg daily) and/or warfarin (target INR = 2.5) | Drug | 1 |
Primary outcome
Two (2) year incidence of stroke or Hard TIA
Time frame: 2 years
All cause mortality for the first 30 days of follow up/discharge, whichever is longer
Time frame: 30 days
Neurological mortality from 31 days of follow up (F/U) or longer
Time frame: 31 days
4 secondary outcomes
Incidence of primary endpoint as a total and broken down by event type/treatment group in: stroke/TIA patients (pts) and DW-MR+ pts with symptoms < 24 hours
Time frame: < 24 hrs
Incidence of primary endpoint in BMT group
Time frame: 2 years
Per treatment group, incidence of relevant/notable adverse events (AEs)
Time frame: 2 years
Device group: (1) Incidence of primary endpoint in pts prescribed aspirin (325 versus 81 mg) daily, (2) Incidence of relevant/notable AEs
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2008.
- Derived from this study: PubMed 25147037Elmariah S, Furlan AJ, Reisman M, Burke D, Vardi M, Wimmer NJ, Ling S, Chen X, Kent DM, Massaro J, Mauri L; CLOSURE I Investigators. Predictors of recurrent events in patients with cryptogenic stroke and patent foramen ovale within the CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale) trial. JACC Cardiovasc Interv. 2014 Aug;7(8):913-20. doi: 10.1016/j.jcin.2014.01.170.
- Derived from this study: PubMed 22417252Furlan AJ, Reisman M, Massaro J, Mauri L, Adams H, Albers GW, Felberg R, Herrmann H, Kar S, Landzberg M, Raizner A, Wechsler L; CLOSURE I Investigators. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med. 2012 Mar 15;366(11):991-9. doi: 10.1056/NEJMoa1009639.
- Derived from this study: PubMed 21051670Furlan AJ, Reisman M, Massaro J, Mauri L, Adams H, Albers GW, Felberg R, Herrmann H, Kar S, Landzberg M, Raizner A, Wechsler L; CLOSURE I Investigators. Study design of the CLOSURE I Trial: a prospective, multicenter, randomized, controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system versus best medical therapy in patients with stroke or transient ischemic attack due to presumed paradoxical embolism through a patent foramen ovale. Stroke. 2010 Dec;41(12):2872-83. doi: 10.1161/STROKEAHA.110.593376. Epub 2010 Nov 4.
- Web site for CLOSURE ILink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Furlan, MD principal investigator
Cleveland Clinic Foundation, Cleveland, OH
Mark Reisman, MD principal investigator
Swedish Medical Center, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing STARFlex septal closure system and Best medical therapy in people with Patent Foramen Ovale and Stroke, run by NMT Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two (2) year incidence of stroke or Hard TIA (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201461, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2008.