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

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...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init