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)

Stroke Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00201461
• Other study ID #: G980031
• Secondary ID: CLOSURE I
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 12, 2005
• Last updated: December 29, 2008
• Start date: June 2003
• Est. completion date: April 2010

Study information

• Verified date: November 2008
• Source: NMT Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Ischemia
• Ischemic Attack, Transient
• Patent Foramen Ovale
• Stroke

Intervention

Device:
• STARFlex septal closure system
transcatheter placement of STARFlex device to close a patent foramen ovale

Drug:
• Best medical therapy
aspirin (325 mg daily) and/or warfarin (target INR = 2.5)

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
NMT Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two (2) year incidence of stroke or Hard TIA		2 years	No
Primary	All cause mortality for the first 30 days of follow up/discharge, whichever is longer		30 days	Yes
Primary	Neurological mortality from 31 days of follow up (F/U) or longer		31 days	Yes
Secondary	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	Yes
Secondary	Incidence of primary endpoint in BMT group		2 years	Yes
Secondary	Per treatment group, incidence of relevant/notable adverse events (AEs)		2 years	Yes
Secondary	Device group: (1) Incidence of primary endpoint in pts prescribed aspirin (325 versus 81 mg) daily, (2) Incidence of relevant/notable AEs		2 years	Yes