The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

NCT01665053 | Completed Phase 3 Results DMC

• 2 other identifiers: S2067G120123
• Study Type: interventional
• Target: 1,684
• Locations: 15 countries
• Sites: 122

Brief Summary

The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Conditions

Coronary Artery Disease

Keywords

Drug-Eluting Stents

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Target Lesion Failure (TLF) at 12 Months

  TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

  12 months

Secondary Outcomes (16)

• Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.

  12 months

• Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.

  12 months

• Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.

  12 months

• Percentage of Participants With Myocardial Infarction at 12 Month.

  12 months

• Percentage of Participants With Cardiac Death at 12 Month.

  12 months

Study Arms (2)

Promus Element Plus

ACTIVE COMPARATOR

PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).

Device: PROMUS Element Plus

SYNERGY

EXPERIMENTAL

SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).

Device: SYNERGY

Interventions

PROMUS Element Plus DEVICE

A drug eluting coronary stent system

Promus Element Plus

SYNERGY DEVICE

A drug eluting coronary stent system

SYNERGY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years of age
• Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
• For subjects less than 20 years of age enrolled at a Japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed
• Subject is eligible for percutaneous coronary intervention (PCI)
• Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
• Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
• Subject is willing to comply with all protocol-required follow-up evaluation
• Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
• Target lesion(s) length must be ≤34 mm (by visual estimate)
• Target lesion(s) must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1 and one of the following: stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
• Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
• The first lesion treated must be successfully predilated/pretreated

You may not qualify if:

• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
• Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
• Subject has received an organ transplant or is on a waiting list for an organ transplant
• Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• Planned PCI (including staged procedures) or CABG after the index procedure
• Subject previously treated at any time with intravascular brachytherapy
• \_ Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
• Subject has one of the following (as assessed prior to the index procedure):
• Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
• Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
• Planned procedure that may cause non-compliance with the protocol or confound data interpretation
• Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
• Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
• Subject has a white blood cell (WBC) count \< 3,000 cells/mm3
• Subject has documented or suspected liver disease, including laboratory evidence of hepatitis

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (126)

Baptist Medical Center - Princeton

Birmingham, Alabama, 35211, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Bakersfield Memorial Hospital

Bakersfield, California, 93301, United States

Location

University of California Davis Health System

Sacramento, California, 95617, United States

Location

Sutter Memorial Hospital

Sacramento, California, 95819, United States

Location

Alvarado Hospital Medical Center

San Diego, California, 92121, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

South Denver Cardiology Associates, PC

Littleton, Colorado, 80120, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Morton Plant Mease Healthcare

Clearwater, Florida, 33756, United States

Location

University of Miami McKnight Brain Institute

Miami, Florida, 33138, United States

Location

MediQuest

Ocala, Florida, 34471, United States

Location

Florida Hospital Medical Center

Orlando, Florida, 32803, United States

Location

Tallahassee Research Institute, Inc.

Tallahassee, Florida, 32308, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

Wellstar Health Systems

Marietta, Georgia, 30060, United States

Location

Kaiser Foundation Hospital

Honolulu, Hawaii, 96819, United States

Location

Kootenai Medical Center

Coeur d'Alene, Idaho, 83814, United States

Location

Prairie Cardiovascular Consultants, Ltd.

Springfield, Illinois, 62701, United States

Location

Northern Indiana Research Alliance

Fort Wayne, Indiana, 46804, United States

Location

St. Vincent's Medical Group, Inc.

Indianapolis, Indiana, 46290, United States

Location

Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Mercy Hospital Medical Center

Des Moines, Iowa, 50314, United States

Location

Kings Daughters Medical Center

Ashland, Kentucky, 41101, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Tufts Medical Center, Inc.

Boston, Massachusetts, 02110, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, 01805, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

St Mary's Duluth Clinic

Duluth, Minnesota, 55805, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Our Lady of Lourdes Medical Center

Haddon Heights, New Jersey, 08035, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

New Mexico Heart Institute, PA

Albuquerque, New Mexico, 87042, United States

Location

Mount Sinai - PRIME

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Moses H. Cone Memorial Hospital-LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27401, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Wake Heart Research, LLC

Raleigh, North Carolina, 27610, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Lindner Center for Research and Education at Christ Hosp

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44103, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Mercy St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Sisters of Charity Providence Hospitals

Columbia, South Carolina, 29204, United States

Location

Jackson Madison County Hospital

Jackson, Tennessee, 38301, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

St. David's Round Rock Medical Center

Round Rock, Texas, 78681, United States

Location

Methodist Texsan Hospital

San Antonio, Texas, 78201, United States

Location

Henrico Doctors Hospital

Richmond, Virginia, 23229, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Aspirus Heart & Vascular Institute

Wausau, Wisconsin, 54401, United States

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Monash Medical Centre-Clayton Campus

Clayton, Victoria, 3168, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, Austria

Location

AKH - Medizinische Universität Wien

Vienna, Austria

Location

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

Location

Z.O.L - Campus St. Jan

Genk, 3600, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

HHrm

Roeselare, 8800, Belgium

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M4, Canada

Location

Institut de Cardiologie de Montreal

Montreal, Quebec, H1T 1C8, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Rigshospitalet Copenhagen

Copenhagen, 2100, Denmark

Location

University Hospital, Heart Centre

Tampere, 33521, Finland

Location

Turku University Hospital

Turku, FI-20520, Finland

Location

CHU de Brest - Hôpital de la Cavale Blanche

Brest, Finistere, 29609, France

Location

CHU de Toulouse - Hôpital Rangueil

Toulouse, Haute Garonne, 31059, France

Location

Clinique Pasteur - Toulouse

Toulouse, Haute Garonne, 31076, France

Location

Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

Bron, Rhone, 69500, France

Location

Clinique Saint-Hilaire - Centre Frédéric Joliot

Rouen, Seine Maritime, 76000, France

Location

Polyclinique Les Fleurs

Ollioules, Var, 83192, France

Location

Centre Hospitalier de Lagny - Marne La Vallée

Lagny-sur-Marne, 77600, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Umberto I Pol. di Roma-Università di Roma La Sapienza

Roma, 161, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, 802-8555, Japan

Location

Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, 247-8533, Japan

Location

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, 230-8765, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

National Cerebral and Cardiovascular Center

Suita-shi, Osaka, 565-8565, Japan

Location

Teikyo University Hospital

Itabashi-ku, Tokyo-To, 173-8606, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo-To, 173-8610, Japan

Location

Toho University Ohashi Medical Center

Meguro-ku, Tokyo-To, 153-8515, Japan

Location

The Cardiovascular Institute

Minatoku, Tokyo-To, 106-0031, Japan

Location

Showa University Hospital

Shinagawa-ku, Tokyo-To, 142-8666, Japan

Location

Department of Cardiology, Tokyo Women's Medical University

Shinjuku-ku, Tokyo-To, 162-8666, Japan

Location

P. Stradins Clinical University Hospital

Riga, LV1002, Latvia

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Medisch Spectrum Twente, Haaksbergerstraat

Enschede, 7513 ER, Netherlands

Location

St. Antonius Ziekenhuis, Nieuwegein

Nieuwegein, 3435CM, Netherlands

Location

Ascot Angiography Ltd

Auckland, 1050, New Zealand

Location

Middlemore Hospital

Auckland, 1640, New Zealand

Location

North Shore Hospital

Auckland, 622, New Zealand

Location

Christchurch Hospital NZ

Christchurch, 8011, New Zealand

Location

SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, 31-501, Poland

Location

SK Przemienienia Panskiego UM im.K.Marcinkowskiego

Poznan, 61-848, Poland

Location

Instytut Kardiologii im.Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

Warsaw, 04-628, Poland

Location

National University Hospital

Singapore, 119228, Singapore

Location

National Heart Centre

Singapore, 168752, Singapore

Location

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (2)

• Kereiakes DJ, Windecker S, Jobe RL, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Underwood P, Allocco DJ, Meredith IT. Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. Circ Cardiovasc Interv. 2019 Sep;12(9):e008152. doi: 10.1161/CIRCINTERVENTIONS.119.008152. Epub 2019 Aug 27.

  PMID: 31451014 DERIVED

• Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Christen T, Allocco DJ, Dawkins KD. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002372. doi: 10.1161/CIRCINTERVENTIONS.114.002372.

  PMID: 25855680 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Patricia O'Mara, Clinical Trial Manager
• Organization: Boston Scientific

patricia.o'mara@bsci.com

518-792-5673

Study Officials

• Peter M Maurer, MPH

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 15, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 22, 2018
• Last Updated: January 30, 2019
• Results First Posted: January 7, 2016

Record last verified: 2019-01

Locations

FR (8); AU (2); ES (3); NL (3); PL (3); US (69); DK (1); JP (12); BE (4); LA (1); CA (5); FI (2); NZ (4); SG (2); IT (3)