Clinical Trial Details

NCT ID: NCT02605447
Date Last Changed: July 26, 2017


Research Study Summary

Patients are needed to participate in a clinical research study evaluating 3 months of dual antiplatelet therapy (DAPT) and SYNERGY Stent System for the treatment of Coronary Artery Disease

Research Study Title

A Prospective, Multicenter, Single-arm Study Designed to Assess the Safety of 3-month Dual Antiplatelet Therapy (DAPT) in Subjects at High Risk for Bleeding Undergoing Percutaneous Coronary Intervention (PCI) With the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System


The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.

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Recruitment Details

18 and up
Overall Status
Lead Sponsor
Boston Scientific Corporation
39 Months
Facility Type


All ages 18 Years and up

Inclusion Criteria:

  1. Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:

  2. ≥ 75 years of age and, in the opinion of the investigator, the risk of major bleeding associated with > 3 months of DAPT outweighs the benefit,

  3. history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,

  4. history of stroke (ischemic or hemorrhagic),

  5. renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),

  6. platelet count ≤100,000/μL

  7. Subject must be at least 18 years of age

  8. Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days

  9. Subject must be able to take study required antiplatelet therapy (as required per protocol)

  10. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 3-month milestone, if eligible per protocol

  11. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed

  12. For subjects less than 20 years of age enrolled at a Japanese site, the subject/ the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed

Exclusion Criteria:

  1. Subject who is taking (or is planning to take) chronic or lifelong anticoagulation within 15 months following index procedure.

  2. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)

  3. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition

  4. Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure

  5. Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).

  6. Subject has a known allergy to contrast (that cannot be adequately pre-medicated), the SYNERGY stent system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)

  7. Subject with implantation of a drug-eluting stent within 9 months prior to index procedure

  8. Subject previously treated at any time with intravascular brachytherapy

  9. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding

  10. Subject is participating in an investigational drug or device clinical trial that has not reached its primary endpoint (Note: registry, observational, data collection studies are not exclusionary)

  11. Subject intends to participate in an investigational drug or device clinical trial within 15 months following the index procedure (Note: registry, observational, data collection studies are not exclusionary)

  12. Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use

  13. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure

  14. Subject is a woman who is pregnant or nursing

  15. Subject with a current medical condition with a life expectancy of less than 15 months

  16. Target lesion(s) is located in the left main

  17. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate

  18. Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)

  19. Planned treatment of more than 3 lesion

  20. Planned treatment of lesions in more than 2 major epicardial vessels

  21. Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)

  22. Target lesion(s) is restenotic from a previous stent implantation

  23. Target lesion(s) is located within a saphenous vein graft or an arterial graft

  24. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing

  25. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Site Locations (106)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85006 Banner Good Samaritan Regional Medical Center
Akil Loli, MD
United States Arizona Phoenix 85013 St. Joseph's Hospital & Medical Center
Hursh Naik, MD
United States Arkansas Little Rock 72205 Baptist Health Medical Center (Little Rock)
Scott Davis, MD
United States Arkansas Little Rock 72211 Arkansas Heart Hospital
David Mego, MD
United States California Bakersfield 93301 Bakersfield Memorial Hospital
Tommy Lee, MD
United States California Los Angeles 90033 USC Medical Center
Ray Matthews, MD
United States California Los Angeles 90048 Cedars - Sinai Medical Center
Suhail Dohad, MD
United States California Riverside 92506 HCA Riverside Community Hospital
Syed Bokhari, MD
United States California Sacramento 95816 Sutter Medical Center, Sacramento
Pei-Hsiu Huang, MD
United States California Sacramento 95817 University of California, Davis Medical Center
Reginald Low, MD
United States California San Francisco 94115 Kaiser Foundation Hospital - San Francisco
Robert Lundstrom, MD
United States California Torrance 90502 Harbor UCLA Medical Center
Quang Bui, MD
United States California Walnut Creek 94598 John Muir Medical Center
Gary Gershony, MD
United States Colorado Littleton 80120 South Denver Cardiology Associates, PC
Lee MacDonald, MD
United States Connecticut New Haven 06510 Yale-New Haven Hospital
Robert Attaran, MD
United States District of Columbia Washington, D.C. 20010 Washington Hospital Center
Ron Waksman, MD
United States Florida Atlantis 33462 JFK Medical Center
Mark Rothenberg, MD
United States Florida Clearwater 33756 Morton Plant Mease Healthcare System
Bernardo Stein, MD
United States Florida Gainesville 32605 North Florida Regional Medical Center
Daniel VanRoy, MD
United States Florida Hollywood 33021 Memorial Regional Hospital
Jonathan Roberts, MD
United States Florida Ocala 34471 Mediquest Research at Munroe Regional Medical Center
Robert Feldman, MD
United States Florida Orlando 32803 Florida Hospital
Rohit Bhatheja, MD
United States Florida Sebring 33870 Florida Hospital Heartland Medical Center
Thomas Shimshak, MD
United States Florida Tallahassee 32308 Tallahassee Memorial Hospital
Wayne Batchelor, MD
United States Georgia Augusta 30901 University Hospital
Patrick Hall, MD
United States Georgia Macon 31201 Medical Center of Central Georgia
Mark Dorogy, MD
United States Georgia Marietta 30060 Wellstar Kennestone Hospital
Amar Patel, MD
United States Idaho Coeur d'Alene 83814 Kootenai Medical Center
Ronald Jenkins, MD
United States Illinois Chicago 60611 Northwestern Memorial Hospital
Mark Ricciardi, MD
United States Illinois Naperville 60566 Edward Hospital
Mark Goodwin, MD
United States Illinois Springfield 62701 St. John's Hospital
Nilesh Goswami, MD
United States Illinois Urbana 61801 Carle Foundation Hospital
Naveed Adoni, MD
United States Indiana Beech Grove 46237 Franciscan St. Francis Hospital
Saeed Shaikh, MD
United States Indiana Fort Wayne 46804 Northern Indiana Research Alliance - Lutheran Hospital
Mark Meier, MD
United States Indiana Indianapolis 46250 Community Heart and Vascular Hospital
Sandeep Dube, MD
United States Iowa Des Moines 50314 Mercy Hospital Medical Center
Magdi Ghali, MD
United States Kentucky Louisville 40202 Jewish Hospital and St. Mary's Healthcare
Naresh Solankhi, MD
United States Louisiana Shreveport 71103 Cardiovascular Research, LLC
James Smith, MD
United States Maine Portland 04102 Maine Medical Center
Samip Vasaiwala, MD
United States Maryland Baltimore 21218 Union Memorial Hospital
John Wang, MD
United States Massachusetts Boston 02111 Tufts Medical Center
Carey Kimmelstiel, MD
United States Massachusetts Boston 02115 Brigham and Women's Hospital
Laura Mauri, MD
United States Massachusetts Boston 02215 Beth Israel Deaconess Medical Center
Duane Pinto, MD
United States Michigan Detroit 48202 Henry Ford Hospital
Khaldoon Alaswad, MD
United States Minnesota Duluth 55805 St. Mary's Duluth Clinic Regional Heart Center
Wilson Ginete, MD
United States Minnesota Minneapolis 55407 Abbott Northwestern Hospital
Ivan Chavez, MD
United States Minnesota Saint Paul 55102 HealthEast St. Joseph's Hospital
Mudassar Ahmed, MD
United States Missouri Kansas City 64111 St. Luke's Hospital of Kansas City
Steven Laster, MD
United States Missouri Saint Louis 63110 Washington University School of Medicine
Jasvindar Singh, MD
United States Missouri Springfield 65802 Cox Medical Centers
Steven Rowe, MD
United States New Hampshire Lebanon 03756-1000 Dartmouth Hitchcock Medical Center
James DeVries, MD
United States New Jersey Browns Mills 08015 Deborah Heart and Lung Center
Richard Kovach, MD
United States New Jersey Morristown 07960 Morristown Memorial Hospital
Jordan Safirstein, MD
United States New Mexico Albuquerque 87106 Presbyterian Hospital
Kayvan Ellini, MD
United States New York Manhasset 11030 North Shore University Hospital
Loukas Boutis, MD
United States New York New York 10016 New York University Medical Center
Michael Attubato, MD
United States New York New York 10032 Columbia University Medical Center/ NewYork Presbyterian Hospital
Manish Parikh, MD
United States New York Syracuse 13202 St. Joseph's Hospital Health Center
Ronald Caputo, MD
United States North Carolina Charlotte 28203 Carolinas Medical Center
Michael Rinaldi, MD
United States North Carolina Raleigh 27610 Wake Medical Center
Islam Othman, MD
United States Ohio Cincinnati 45219 Lindner Center for Research and Education at Christ Hospital
Dean Kereiakes, MD
United States Ohio Cincinnati 45220 Good Samaritan Hospital
Dogan Temizer, MD
United States Ohio Columbus 03210 Ohio State University Medical Center
Cindy Baker, MD
United States Ohio Columbus 43214 OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Steven Yakubov, MD
United States Ohio Toledo 43608 Mercy St. Vincent Medical Center
Ameer Kabour, MD
United States Oklahoma Oklahoma City 73112 Integris Baptist Medical Center
George Chrysant, MD
United States Oklahoma Oklahoma City 73120 Oklahoma Heart Hospital
Naeem Tahirkheli, MD
United States Oregon Portland 97225 Providence St. Vincent Medical Center
Ethan Korngold, MD
United States Pennsylvania Danville 17822 Geisinger Medical Center
James Blankenship, MD
United States Pennsylvania Pittsburgh 15213 University of Pittsburgh Medical Center
Saul Silver, MD
United States Pennsylvania Wynnewood 19096 Lankenau Hospital
Timothy Shapiro, MD
United States South Carolina Columbia 29204 Sisters of Charity Providence Hospital
Michael Foster, MD
United States South Carolina Greenville 29605 University Medical Center-Greenville Memorial Hospital
Joseph Henderson, MD
United States South Carolina Myrtle Beach 29572 Grand Strand Regional Medical Center
Randy Goodroe, MD
United States Tennessee Jackson 38301 Jackson-Madison County General Hospital
Henry Lui, MD
United States Tennessee Nashville 37203 Centennial Medical Center
Brian Jefferson, MD
United States Texas Dallas 75226 Baylor Heart & Vascular Hospital
Robert Stoler, MD
United States Texas Houston 77030 St. Luke's Episcopal Hospital
Ali Mortazavi, MD
United States Texas Houston 77074 Memorial Hermann Southwest
Pranav Loyalka, MD
United States Texas Plano 75093 The Heart Hospital Baylor Plano
Molly Szerlip, MD
United States Texas Round Rock 78681 St. David's Round Rock Medical Center
Craig Siegel, MD
United States Vermont Burlington 05401 The University of Vermont Medical Center
Harold Dauerman, MD
United States Virginia Norfolk 23507 Sentara Norfolk General Hospital
Neville Mistry, MD
United States Virginia Winchester 26015 Winchester Medical Center
Jason Call, MD
United States Washington Seattle 98122 Swedish Medical Center
Jeffrey Westcott, MD
United States Washington Seattle 98195 University of Washington Medical Center
Creighton Don, MD
United States West Virginia Charleston 25304 Charleston Area Medical Center
Elie Gharib, MD
United States Wisconsin Milwaukee 53215 Aurora St. Luke's Medical Center
Suhail Allaqaband, MD
United States Wisconsin Wausau 54401 Aspirus Heart and Vascular Institute - Research and Education
Timothy Grady, MD
Brazil Sao Paulo 05403-000 Instituto do Coração (InCor)
Pedro Lemos, MD
+55 11 2661-5961
Brazil São Paulo 04012-909 Instituto de Cardiologia Dante Pazzanese
Alexandre Antonio Cunha Abizaid, MD
+55 1150854141
Germany Bad Krozingen 79189 Herzzentrum Bad Krozingen
Franz-Josef Neumann, Prof, MD
+49 7633 402-2001
Germany Bad Segeberg 23795 Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Ralph Ernst Toelg, MD
+49 4551 802 4801
Germany Heidelberg 69120 Universitaetsklinikum Heidelberg
Raffi Bekeredjian, MD
+49 6221-56-38797
Germany Jena 07740 Uni Jena
Christian Schultz, MD
Japan Fukuoka Fukuoka-shi 814-0001 Fukuoka Sanno Hospital
Hiroyoshi Yokoi, MD
Japan Kanagawa Isehara-shi 259-1193 Tokai University Hospital
Yuji Ikari, MD
Japan Kanagawa Yokohama-shi 230-8765 Saiseikai Yokohama-City Eastern Hospital
Yoshiaki Ito, MD
Japan Tokyo Itabashi-ku 173-8606 Teikyo University Hospital
Ken Kozuma, MD
Japan Tokyo Meguro-ku 153-8515 Toho University Ohashi Medical Center
Masato Nakamura, MD
Japan Osaka Osaka Saiseikai Nakatsu Hospital
Junya Shite, MD
Latvia Riga LV-1002 P. Stradins University Hospital
Andrejs Erglis, MD
+371 67069379
Sweden Falun 79182 Falu Lasarett
Iwar Sjoegren, MD
+462) 349-0979
Sweden Karlstad 65185 Karlstadt Central Hospital
Hans Olsson, MD
Sweden Malmo SE-214 28 Skane University Hospital
Matthias Goetberg, MD
+46 46 17 76 77
Switzerland Fribourg 1708 Hospital Cantonal Fribourg
Stephane Cook, MD


Peter Maurer

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