• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Boston Scientific enrolls first patient in coronary stent study featuring bioabsorbable polymer coating

Boston Scientific enrolls first patient in coronary stent study featuring bioabsorbable polymer coating

November 30, 2012
CenterWatch Staff

The first patient has been enrolled in Boston Scientific’s EVOLVE II clinical trial, designed to further assess the safety and effectiveness of the SYNERGY Stent System and support FDA and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.  

Boston Scientific received CE Mark approval for the SYNERGY Stent System in October 2012. The EVOLVE II clinical program is anticipated to enroll approximately 2,000 patients at up to 160 sites worldwide including the U.S., Canada, Europe, Australia, New Zealand, Japan, India, Brazil and Singapore, and the first patient was enrolled at the Christ Hospital, Lindner Research Center in Cincinnati, Ohio.

The SYNERGY Stent uses the market-leading everolimus drug and features an ultra-thin bioabsorbable polymer coating. The absorption of the polymer is completed shortly after drug elution ends at three months.

"SYNERGY is the most flexible, conformable and deliverable drug eluting stent platform that I have ever deployed," said Dean Kereiakes, M.D., F.A.C.C., Christ Hospital and the principal investigator of the study. "I am enthusiastic about its potential impact on patient care since the SYNERGY System was designed to reduce the risk of late adverse events and the need for prolonged dual antiplatelet therapy, which is often associated with a higher risk of bleeding, as well as increased cost."

The EVOLVE II clinical trial builds upon the EVOLVE study. EVOLVE was a prospective, randomized, single-blind, first human use study comparing the SYNERGY Stent to the PROMUS Element Stent, which uses a durable polymer coating. Outcomes with the SYNERGY Stent in EVOLVE were comparable to outcomes with the PROMUS Element Stent at six months and one year.

"We continue to strengthen our drug-eluting stent portfolio with innovations like the SYNERGY System in an effort to increase the advanced treatment options available to physicians and patients," said Kevin Ballinger, president of interventional cardiology at Boston Scientific.

"This underscores our commitment to the drug-eluting stent market and reinforces our position as a global market leader."

Patients enrolled in the EVOLVE II trial will be followed for five years. The SYNERGY Stent System is an investigational device in non-CE Mark countries and is not available for sale in the U.S. and Japan.

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing