Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
2009 participants
INTERVENTIONAL
2016-02-16
2019-07-17
Brief Summary
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Detailed Description
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The study will be conducted up to 120 sites worldwide in the United States, Europe, Japan, and Brazil with planned enrollment of up to 2,250 subjects. Clinical follow-up will be required at the following time points: 3 months, 6 months, 12 months and 15 months post index procedure.
Subjects must be treated with one of the following P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor) for 3 months following the index procedure. Subjects must be treated with aspirin for the duration of the trial. The minimum daily maintenance dose of aspirin should be 75-100 mg.
Subjects are eligible for discontinuation of P2Y12 inhibitor at 3 months if they meet both of the following criteria: subject was treated with 3 months of study required antiplatelet therapy post index procedure; and subject was free from events (stroke, MI, PCI, coronary artery bypass graft \[CABG\], and stent thrombosis) between the index procedure and the 3 month visit.
Subjects are not eligible for discontinuation of P2Y12 inhibitor at 3 months if any of the following criteria are met: subject who experiences a stroke, MI, PCI, CABG and/or stent thrombosis, during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject who is non-compliant with study required antiplatelet therapy during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months due to another condition requiring chronic P2Y12 inhibitor use.
All enrolled subjects who receive a SYNERGY stent must be followed at all milestones through 15-months, regardless of eligibility to discontinue P2Y12 inhibitor. Following the 3-month milestone, subjects who experience MI or stent thrombosis events should be treated per the investigator's discretion and should be followed through the 15-month visit.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SYNERGY stent + 3 month DAPT
Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)
3 months of dual antiplatelet therapy (DAPT)
3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin
SYNERGY Stent System
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Interventions
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3 months of dual antiplatelet therapy (DAPT)
3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin
SYNERGY Stent System
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Eligibility Criteria
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Inclusion Criteria
* ≥ 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,
* need for chronic or lifelong anticoagulation,
* history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,
* history of stroke (ischemic or hemorrhagic),
* renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),
* platelet count ≤100,000/μL
2. Subject must be at least 18 years of age
3. Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days
4. Subject must be able to take study required antiplatelet therapy (as required per protocol)
5. 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
6. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed
7. 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
2. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
3. Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure
4. Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).
5. 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)
6. Subject with implantation of a drug-eluting stent within 9 months prior to index procedure
7. Subject previously treated at any time with intravascular brachytherapy
8. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
9. 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)
10. 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)
11. Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use
12. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure
13. Subject is a woman who is pregnant or nursing
14. Subject with a current medical condition with a life expectancy of less than 15 months
15. Target lesion(s) is located in the left main
16. 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
17. Subject has unprotected left main coronary artery disease ( \> 50% diameter stenosis)
18. Planned treatment of more than 3 lesion
19. Planned treatment of lesions in more than 2 major epicardial vessels
20. Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)
21. Target lesion(s) is restenotic from a previous stent implantation
22. Target lesion(s) is located within a saphenous vein graft or an arterial graft
23. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
24. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ajay Kirtane, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University Medical Center/ NewYork Presbyterian Hospital
Stephan Windecker, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
INSELSPITAL - Universitätsspital Bern
Locations
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Banner Good Samaritan Regional Medical Center
Phoenix, Arizona, United States
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Baptist Health Medical Center (Little Rock)
Little Rock, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Bakersfield Memorial Hospital
Bakersfield, California, United States
USC Medical Center
Los Angeles, California, United States
Cedars - Sinai Medical Center
Los Angeles, California, United States
El Camino Hospital
Mountain View, California, United States
HCA Riverside Community Hospital
Riverside, California, United States
Sutter Medical Center, Sacramento
Sacramento, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Kaiser Foundation Hospital - San Francisco
San Francisco, California, United States
John Muir Medical Center
Walnut Creek, California, United States
South Denver Cardiology Associates, PC
Littleton, Colorado, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
JFK Medical Center
Atlantis, Florida, United States
Morton Plant Mease Healthcare System
Clearwater, Florida, United States
North Florida Regional Medical Center
Gainesville, Florida, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Mediquest Research at Munroe Regional Medical Center
Ocala, Florida, United States
Florida Hospital
Orlando, Florida, United States
Florida Hospital Heartland Medical Center
Sebring, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
University Hospital
Augusta, Georgia, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Edward Hospital
Naperville, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Franciscan St. Francis Hospital
Beech Grove, Indiana, United States
Northern Indiana Research Alliance - Lutheran Hospital
Fort Wayne, Indiana, United States
Community Heart and Vascular Hospital
Indianapolis, Indiana, United States
Mercy Hospital Medical Center
Des Moines, Iowa, United States
Jewish Hospital and St. Mary's Healthcare
Louisville, Kentucky, United States
Cardiovascular Research, LLC
Shreveport, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Cox Medical Centers
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Presbyterian Hospital
Albuquerque, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
New York University Medical Center
New York, New York, United States
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, United States
St. Joseph's Hospital Health Center
Syracuse, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Wake Medical Center
Raleigh, North Carolina, United States
Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Sisters of Charity Providence Hospital
Columbia, South Carolina, United States
University Medical Center-Greenville Memorial Hospital
Greenville, South Carolina, United States
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Centennial Medical Center
Nashville, Tennessee, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
St. David's Round Rock Medical Center
Round Rock, Texas, United States
The University of Vermont Medical Center
Burlington, Vermont, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Winchester Medical Center
Winchester, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Aspirus Heart and Vascular Institute - Research and Education
Wausau, Wisconsin, United States
Instituto de Cardiologia Dante Pazzanese
São Paulo, , Brazil
Instituto do Coração (InCor)
São Paulo, , Brazil
Herzzentrum Bad Krozingen
Bad Krozingen, , Germany
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Bad Segeberg, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Uni Jena
Jena, , Germany
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, Japan
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, Japan
Saiseikai Yokohama-City Eastern Hospital
Yokohama, Kanagawa, Japan
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, Japan
Kurume University Hospital
Kurume-shi, , Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, , Japan
P. Stradins University Hospital
Riga, , Latvia
Falu Lasarett
Falun, , Sweden
Karlstadt Central Hospital
Karlstad, , Sweden
Skane University Hospital
Malmo, , Sweden
Hospital Cantonal Fribourg
Fribourg, , Switzerland
Countries
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References
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Mihatov N, Kirtane AJ, Stoler R, Feldman R, Neumann FJ, Boutis L, Tahirkheli N, Kereiakes DJ, Toelg R, Othman I, Stein B, Allocco D, Windecker S, Yeh RW. Bleeding and Ischemic Risk Prediction in Patients With High Bleeding Risk (an EVOLVE Short DAPT Analysis). Am J Cardiol. 2023 Nov 15;207:370-379. doi: 10.1016/j.amjcard.2023.06.036. Epub 2023 Sep 29.
Kirtane AJ, Stoler R, Feldman R, Neumann FJ, Boutis L, Tahirkheli N, Toelg R, Othman I, Stein B, Choi JW, Windecker S, Yeh RW, Dauerman HL, Price MJ, Underwood P, Allocco D, Meredith I, Kereiakes DJ. Primary Results of the EVOLVE Short DAPT Study: Evaluation of 3-Month Dual Antiplatelet Therapy in High Bleeding Risk Patients Treated With a Bioabsorbable Polymer-Coated Everolimus-Eluting Stent. Circ Cardiovasc Interv. 2021 Mar;14(3):e010144. doi: 10.1161/CIRCINTERVENTIONS.120.010144. Epub 2021 Mar 1.
Balanescu DV, Aziz MK, Donisan T, Palaskas N, Lopez-Mattei J, Hassan S, Kim P, Song J, Ntim W, Cilingiroglu M, Marmagkiolis K, Iliescu C. Cancer treatment resumption in patients with new-generation drug-eluting stents. Coron Artery Dis. 2021 Jun 1;32(4):295-301. doi: 10.1097/MCA.0000000000000986.
Mauri L, Kirtane AJ, Windecker S, Yeh RW, Dauerman HL, Price MJ, Christen T, Allocco DJ, Meredith IT, Kereiakes DJ. Rationale and design of the EVOLVE Short DAPT Study to assess 3-month dual antiplatelet therapy in subjects at high risk for bleeding undergoing percutaneous coronary intervention. Am Heart J. 2018 Nov;205:110-117. doi: 10.1016/j.ahj.2018.08.004. Epub 2018 Aug 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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S2073
Identifier Type: -
Identifier Source: org_study_id
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