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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
Est. primary completion date
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


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
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