News | April 10, 2009

CLOSURE I Trial for STARFlex PFO Closure Device Will be Completed in Late 2010

April 10, 2009 - NMT Medical Inc. said this week data analysis for its STARFlex device for patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) clinical trial, CLOSURE I, will remain scheduled for the fourth quarter of 2010.

The company then expects to submit a pre-market approval (PMA) application for its STARFlex device for the stroke and TIA indication to the U.S. Food and Drug Administration (FDA) soon after the data analysis is completed.

With the approval of the trial’s Executive Committee, NMT recently received the findings of an independent statistical review committee regarding the timing of CLOSURE I data analysis. The independent statistical committee comprised of biostatisticians and trial design experts, whose charter had been previously approved by the FDA, determined that it was “highly likely” that sufficient primary outcome events (strokes and TIAs) would have occurred so that an analysis could be performed in October 2009 - one year earlier than originally planned. At that time, 93 percent of the trial data will be available and all patients will have completed at least one year of follow-up. However, while an early event driven analysis may be statistically valid, the CLOSURE I Executive Committee advised that the conservative pathway that offers the best statistical power to observe a significant difference in treatment alternatives would be to follow the original trial timeline. As a result, NMT has decided at this time to maintain the two-year timetable for data analysis.

NMT said the trial might provide the clinical stroke community with an early answer to one of the most important and vexing problems in stroke neurology today - whether PFO closure prevents ongoing damage to the brain from recurrent strokes and TIAs.

The trial is being led by Principal Investigators Anthony Furlan, M.D., and Mark Reisman, M.D. Dr. Furlan is chairman, department of neurology, Neurological Institute University Hospitals Case Medical Center, and Case Western Reserve University School of Medicine in Cleveland. Dr. Reisman is director, cardiovascular research and director, cardiac catheterization lab, Swedish Heart and Vascular Institute in Seattle.
“The results from CLOSURE I will provide valuable insight on how to best reduce recurrent stroke risk in patients with a PFO,” Dr. Furlan said. “The trial is designed to determine if PFO closure is a more effective treatment than medical therapy alone for patients with cryptogenic stroke and TIA. While the medical community eagerly awaits the results of this important trial, we applaud NMT’s current decision to maintain the original data analysis timetable, which will provide maximum statistical power. On the other hand, it is of some reassurance that the independent statistical committee indicated that we will likely have enough primary outcome events to detect a significant result as early as October 2009.”

“This landmark study and its anticipated results have generated a high level of interest within both the cardiology and neurology communities,” said Dr. Reisman. “However, there is no scientific advantage to changing the decision about the timing of the data analysis today.”

Martin concluded, “We all are eager to uncover the connection between PFO, stroke and TIA, but we decided not to accelerate the data analysis schedule at this time. We would like to acknowledge and thank the more than 190 leading stroke neurologist and interventional cardiologist investigators, their research teams, the enrolled patients, and our employees and shareholders for their continued commitment to the CLOSURE I trial.”

A PFO is a common heart defect that may be a potential risk factor for stroke, TIA, migraine or other brain attacks in some patients. The PFO allows venous blood, unfiltered and unmanaged by the lungs, to enter the arterial blood circulation. CLOSURE I is designed to evaluate the effectiveness of NMT’s STARFlex implant technology in preventing recurrent stroke and/or TIA due to a presumed, paradoxical embolism through a PFO. More than 190 leading stroke neurologists and interventional cardiologists at approximately 95 centers in the U.S., Canada and the U.K. are participating in the study. Of the 910 stroke and TIA patients enrolled, half received PFO closure in a catheter-based procedure with NMT's STARFlex implant and half were treated with drugs alone.

For more information:

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init