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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by NMT Medical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NMT Medical
ClinicalTrials.gov Identifier:
NCT00201461
First received: September 12, 2005
Last updated: December 29, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Patent Foramen Ovale
Stroke
Ischemic Attack, Transient
Device: STARFlex septal closure system
Drug: Best medical therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NMT Medical:

Primary Outcome Measures:
  • Two (2) year incidence of stroke or Hard TIA [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • All cause mortality for the first 30 days of follow up/discharge, whichever is longer [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Neurological mortality from 31 days of follow up (F/U) or longer [ Time Frame: 31 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence of primary endpoint in BMT group [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Per treatment group, incidence of relevant/notable adverse events (AEs) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 900
Study Start Date: June 2003
Estimated Study Completion Date: April 2010
Arms Assigned Interventions
Active Comparator: 1
Best medical therapy
Drug: Best medical therapy
aspirin (325 mg daily) and/or warfarin (target INR = 2.5)
Experimental: 2
STARFlex arm
Device: STARFlex septal closure system
transcatheter placement of STARFlex device to close a patent foramen ovale

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201461

Locations
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
NMT Medical
Investigators
Principal Investigator: Anthony Furlan, MD Cleveland Clinic Foundation, Cleveland, OH
Principal Investigator: Mark Reisman, MD Swedish Medical Center, Seattle, WA
  More Information

Additional Information:
No publications provided by NMT Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00201461     History of Changes
Other Study ID Numbers: G980031, CLOSURE I
Study First Received: September 12, 2005
Last Updated: December 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by NMT Medical:
Patent Foramen Ovale
STARFlex
CLOSURE I
Septal Closure System
Stroke
Cerebrovascular Accident
Transient Ischemic Attack
Heart Septal Defects, Atrial

Additional relevant MeSH terms:
Ischemic Attack, Transient
Foramen Ovale, Patent
Ischemia
Stroke
Cerebral Infarction
Embolism, Paradoxical
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
Pathologic Processes
Brain Infarction
Thromboembolism
Embolism and Thrombosis
Thrombosis

ClinicalTrials.gov processed this record on July 28, 2014