Bos Sci launches bioabsorbable polymer stent trial
Boston Scientific has begun patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of its Synergy coronary stent, which uses a bioabsorbable PLGA polymer and everolimus drug formulation to create a uniform coating confined to the outer surface of the stent.
The Synergy stent features the same platinum chromium alloy and stent design used in the Promus Element stent, according to the Natick, Mass.-based company.
The EVOLVE trial is a randomized, single-blind, non-inferiority clinical trial that will enroll 291 patients at up to 35 sites in Europe, Australia and New Zealand.
Boston Scientific said the trial will compare the Synergy stent to the Promus Element everolimus-eluting coronary stent in patients with a single de novo native coronary artery lesion.
Two drug doses will be evaluated with the Synergy stent, including an everolimus dose approximately equal to that of the Promus Element stent and a dose equivalent to half that amount.
The primary clinical endpoint is target lesion failure at 30 days, a composite measure of cardiac death, MI and target lesion revascularization. The primary angiographic endpoint is in-stent late loss at six-months as measured by quantitative coronary angiography.
Clinical follow-up will occur at 30 days, six months, nine months and every 12 months out to five years. In addition, all patients will undergo intravascular ultrasound at the time of the initial procedure and at six months. Patient enrollment in the trial is scheduled to be completed by mid 2011. Data from the trial will be used to support CE mark for the Synergy stent.
The first patient was enrolled by Ian Meredith, PhD, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia. Principal investigators for the trial are Meredith and Stefan Verheye, MD, PhD, from the department of interventional cardiology at Middelheim Hospital in Antwerp, Belgium.
The Synergy stent features the same platinum chromium alloy and stent design used in the Promus Element stent, according to the Natick, Mass.-based company.
The EVOLVE trial is a randomized, single-blind, non-inferiority clinical trial that will enroll 291 patients at up to 35 sites in Europe, Australia and New Zealand.
Boston Scientific said the trial will compare the Synergy stent to the Promus Element everolimus-eluting coronary stent in patients with a single de novo native coronary artery lesion.
Two drug doses will be evaluated with the Synergy stent, including an everolimus dose approximately equal to that of the Promus Element stent and a dose equivalent to half that amount.
The primary clinical endpoint is target lesion failure at 30 days, a composite measure of cardiac death, MI and target lesion revascularization. The primary angiographic endpoint is in-stent late loss at six-months as measured by quantitative coronary angiography.
Clinical follow-up will occur at 30 days, six months, nine months and every 12 months out to five years. In addition, all patients will undergo intravascular ultrasound at the time of the initial procedure and at six months. Patient enrollment in the trial is scheduled to be completed by mid 2011. Data from the trial will be used to support CE mark for the Synergy stent.
The first patient was enrolled by Ian Meredith, PhD, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia. Principal investigators for the trial are Meredith and Stefan Verheye, MD, PhD, from the department of interventional cardiology at Middelheim Hospital in Antwerp, Belgium.