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)

NCT00201461 | Unknown Phase 2 DMC

• 2 other identifiers: G980031CLOSURE I
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Two (2) year incidence of stroke or Hard TIA

  2 years

• All cause mortality for the first 30 days of follow up/discharge, whichever is longer

  30 days

• Neurological mortality from 31 days of follow up (F/U) or longer

  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

  < 24 hrs

• Incidence of primary endpoint in BMT group

  2 years

• Per treatment group, incidence of relevant/notable adverse events (AEs)

  2 years

• Device group: (1) Incidence of primary endpoint in pts prescribed aspirin (325 versus 81 mg) daily, (2) Incidence of relevant/notable AEs

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Best medical therapy

Drug: Best medical therapy

2

EXPERIMENTAL

STARFlex arm

Device: STARFlex septal closure system

Interventions

STARFlex septal closure system DEVICE

transcatheter placement of STARFlex device to close a patent foramen ovale

2

Best medical therapy DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NMT Medical: lead

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

• 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.

  PMID: 25147037 DERIVED

• 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.

  PMID: 22417252 DERIVED

• 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.

  PMID: 21051670 DERIVED

MeSH Terms

Conditions

Foramen Ovale, Patent; Stroke; Ischemic Attack, Transient; Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Brain Ischemia

Study Officials

• Anthony Furlan, MD

  Cleveland Clinic Foundation, Cleveland, OH

  PRINCIPAL INVESTIGATOR

• Mark Reisman, MD

  Swedish Medical Center, Seattle, WA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2003
• Study Completion: April 1, 2010
• Last Updated: December 30, 2008

Record last verified: 2008-11

Locations

US (1)