Overview

This trial is active, not recruiting.

Conditions patent foramen ovale, stroke, ischemic attack, transient
Treatments starflex septal closure system, best medical therapy
Phase phase 2/phase 3
Sponsor NMT Medical
Start date June 2003
End date April 2010
Trial size 900 participants
Trial identifier NCT00201461, CLOSURE I, G980031

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Best medical therapy
best medical therapy
aspirin (325 mg daily) and/or warfarin (target INR = 2.5)
(Experimental)
STARFlex arm
starflex septal closure system
transcatheter placement of STARFlex device to close a patent foramen ovale

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

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
Principal investigator Anthony Furlan, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2008.
Information provided to ClinicalTrials.gov by NMT Medical.