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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)

Information source: NMT Medical
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Patent Foramen Ovale; Stroke; Ischemic Attack, Transient

Intervention: STARFlex septal closure system (Device); Best medical therapy (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: NMT Medical

Official(s) and/or principal investigator(s):
Anthony Furlan, MD, Principal Investigator, Affiliation: Cleveland Clinic Foundation, Cleveland, OH
Mark Reisman, MD, Principal Investigator, Affiliation: Swedish Medical Center, Seattle, WA

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.

Clinical Details

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

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

Primary outcome:

Two (2) year incidence of stroke or Hard TIA

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

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

Secondary outcome:

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

Incidence of primary endpoint in BMT group

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
Additional Information

Web site for CLOSURE I

Starting date: June 2003
Last updated: December 29, 2008

Page last updated: August 20, 2015

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