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)

NCT ID: NCT00201461

Last Updated: 2008-12-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2010-04-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Best medical therapy

Group Type: ACTIVE_COMPARATOR

Best medical therapy

Intervention Type: DRUG

aspirin (325 mg daily) and/or warfarin (target INR = 2.5)

2

STARFlex arm

Group Type: EXPERIMENTAL

STARFlex septal closure system

Intervention Type: DEVICE

transcatheter placement of STARFlex device to close a patent foramen ovale

Interventions

STARFlex septal closure system

transcatheter placement of STARFlex device to close a patent foramen ovale

Intervention Type: DEVICE

Best medical therapy

aspirin (325 mg daily) and/or warfarin (target INR = 2.5)

Intervention Type: DRUG

Eligibility Criteria

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.

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NMT Medical

INDUSTRY

Sponsor Role: lead

Principal Investigators

Anthony Furlan, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Foundation, Cleveland, OH

Mark Reisman, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center, Seattle, WA

Locations

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25147037 (View on PubMed)

Furlan 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.

Reference Type: DERIVED

PMID: 22417252 (View on PubMed)

Furlan 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.

Reference Type: DERIVED

PMID: 21051670 (View on PubMed)

Other Identifiers

CLOSURE I

Identifier Type: -

Identifier Source: secondary_id

G980031

Identifier Type: -

Identifier Source: org_study_id