Journal article
Study Design of the CLOSURE I Trial: 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 Stroke or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale
Stroke (1970), Vol.41(12), pp.2872-2883
2010
DOI: 10.1161/STROKEAHA.110.593376
PMID: 21051670
Abstract
Background and Purpose—Some strokes of unknown etiology may be the result of a paradoxical embolism traversing through a nonfused foramen ovale (patent foramen ovale [PFO]). The utility of percutaneously placed devices for treatment of patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO is unknown. In addition, there are no clear data about the utility of medical interventions or other surgical procedures in this situation. Despite limited data, many patients are being treated with PFO closure devices. Thus, there is a strong need for clinical trials that test the potential efficacy of PFO occlusive devices in this situation. To address this gap in medical knowledge, we designed the CLOSURE I trial, a randomized, clinical trial comparing the use of a percutaneously placed PFO occlusive device and best medical therapy versus best medical therapy alone for prevention of recurrent ischemic neurologic symptoms among persons with TIA or ischemic stroke.
Study Design—This prospective, multicenter, randomized, controlled trial has finished enrollment. Two-year follow-up for all 910 patients is required. The primary end point is the 2-year incidence of stroke or TIA, all-cause mortality for the first 30 days, and neurologic mortality from ≥31 days of follow-up, as adjudicated by a panel of physicians who are unaware of treatment allocation. This article describes the rationale and study design of CLOSURE I.
Conclusions—This trial should provide information as to whether the STARFlex septal closure system is safe and more effective than best medical therapy alone in preventing recurrent stroke/TIA and mortality in patients with PFO and whether the STARFlex septal closure device can demonstrate superiority compared with best medical therapy alone.
Details
- Title: Subtitle
- Study Design of the CLOSURE I Trial: 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 Stroke or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale
- Creators
- Anthony J FURLAN - University Hospitals, Case Medical Center, Cleveland, Ohio, United StatesMark REISMAN - Swedish Medical Center, Seattle, Wash, United StatesAlbert RAIZNER - Methodist Hospital, Houston, Tex, United StatesLawrence WECHSLER - University of Pittsburgh, Pittsburgh, Pa, United StatesJoseph MASSARO - Harvard Clinical Research Institute, Boston, Mass, United StatesLaura MAURI - Harvard Clinical Research Institute, Boston, Mass, United StatesHarold Adams - University of Iowa, Iowa City, Iowa, United StatesGregory W ALBERS - Stanford University Medical Center, Palo Alto, Calif, United StatesRobert FELBERG - Geisinger Medical Center, Danville, Pa, United StatesHoward HERRMANN - University of Pennsylvania, Philadelphia, Pa, United StatesSaibal KAR - Cedars Sinai Medical Center, Los Angeles, Calif, United StatesMichael LANDZBERG - Brigham and Women's Hospital, Boston, Mass, United States
- Resource Type
- Journal article
- Publication Details
- Stroke (1970), Vol.41(12), pp.2872-2883
- DOI
- 10.1161/STROKEAHA.110.593376
- PMID
- 21051670
- NLM abbreviation
- Stroke
- ISSN
- 0039-2499
- eISSN
- 1524-4628
- Publisher
- Lippincott Williams & Wilkins; Hagerstown, MD
- Language
- English
- Date published
- 2010
- Academic Unit
- Neurology; Iowa Neuroscience Institute
- Record Identifier
- 9984020650302771
Metrics
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