News | January 24, 2011

Trial Enrollment Completed for Stent With Bioabsorbable Polymer

January 24, 2011 – Patient enrollment was completed in the EVOLVE clinical trial, which is designed to assess the safety and performance of the Boston Scientific's fourth-generation Synergy coronary stent, which uses a bioabsorbable drug-eluting polymer.

The randomized, single-blind, non-inferiority trial will compare the stent to the Promus Element everolimus-eluting coronary stent in patients with a single de novo native coronary artery lesion. The trial enrolled 291 patients at 29 sites in Europe, Australia and New Zealand, and completed enrollment four months ahead of schedule.

The Synergy stent uses a bioabsorbable PLGA polymer and everolimus drug combination to create a thin, uniform coating confined to the outer surface of the stent. Once the drug has been delivered, the bioabsorbable coating resorbs in three to six months, leaving behind only a bare-metal stent. This technology is designed to provide the same degree of restenosis reduction as a conventional drug-eluting stent, while offering faster and more complete vessel healing after stent implantation. This could potentially reduce the duration of required antiplatelet therapies.

The stent features the same proprietary platinum chromium alloy and stent design used in the Promus Element, which enables thinner struts, increased flexibility and a lower profile, while reducing recoil and improving radial strength and visibility.

"We are pleased to complete the enrollment phase of the EVOLVE clinical trial well ahead of schedule," said professor Ian Meredith, MBBS, Ph.D., director of MonashHeart, Monash Medical Centre, Melbourne, Australia, and principal investigator of the trial. "The brisk pace of enrollment reflects the strong interest in this innovative drug-eluting stent technology that could play an important role in helping reduce adverse events including late stent thrombosis."

The stent will reduce the amount of polymer and drug to which the vessel wall is exposed, while eliminating the coating on the inner surface of the stent where endothelial cell growth is required for healing.

The EVOLVE trial compares two doses of everolimus on the Synergy Stent (a Promus Element equivalent dose and a dose half that amount) randomized against a commercially available Promus Element stent. The primary clinical endpoint is target lesion failure at 30 days, a composite measure of cardiac death, myocardial infarction and target lesion revascularization. The primary angiographic endpoint is in-stent late loss at six months as measured by quantitative coronary angiography (QCA). Patients will also be assessed by intravascular ultrasound (IVUS) at the time of initial procedure and at six months. Data from the trial will be used to support CE mark approval for the SYNERGY stent.

In the United States, the Synergy stent and the Promus Element are investigational devices and are limited by applicable law to investigational use only and are not available for sale. The company received CE mark approval for the Promus Element in October 2009.

For more information: www.bostonscientific.com

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
Overlay Init