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

NCT ID: NCT01665053

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1684 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2018-12-22

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).

Detailed Description

A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive, non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Promus Element Plus

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).

Group Type: ACTIVE_COMPARATOR

PROMUS Element Plus

Intervention Type: DEVICE

A drug eluting coronary stent system

SYNERGY

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).

Group Type: EXPERIMENTAL

SYNERGY

Intervention Type: DEVICE

A drug eluting coronary stent system

Interventions

PROMUS Element Plus

A drug eluting coronary stent system

Intervention Type: DEVICE

SYNERGY

A drug eluting coronary stent system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
• Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
• Subject has severe symptomatic heart failure (i.e., NYHA class IV)
• Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
• Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
• Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
• Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)

• Planned treatment of more than 3 lesions
• Planned treatment of lesions in more than 2 major epicardial vessels
• Planned treatment of a single lesion with more than 1 stent
• Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
• Target lesion(s) is located in the left main
• 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
• Target lesion(s) is located within a saphenous vein graft or an arterial graft
• Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
• Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
• Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
• Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
• Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
• Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
• Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter M Maurer, MPH

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

Baptist Medical Center - Princeton

Birmingham, Alabama, United States

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Bakersfield Memorial Hospital

Bakersfield, California, United States

University of California Davis Health System

Sacramento, California, United States

Sutter Memorial Hospital

Sacramento, California, United States

Alvarado Hospital Medical Center

San Diego, California, United States

North Colorado Medical Center

Greeley, Colorado, United States

South Denver Cardiology Associates, PC

Littleton, Colorado, United States

Washington Hospital Center

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

Morton Plant Mease Healthcare

Clearwater, Florida, United States

University of Miami McKnight Brain Institute

Miami, Florida, United States

MediQuest

Ocala, Florida, United States

Florida Hospital Medical Center

Orlando, Florida, United States

Tallahassee Research Institute, Inc.

Tallahassee, Florida, United States

Medical Center of Central Georgia

Macon, Georgia, United States

Wellstar Health Systems

Marietta, Georgia, United States

Kaiser Foundation Hospital

Honolulu, Hawaii, United States

Kootenai Medical Center

Coeur d'Alene, Idaho, United States

Prairie Cardiovascular Consultants, Ltd.

Springfield, Illinois, United States

Northern Indiana Research Alliance

Fort Wayne, Indiana, United States

St. Vincent's Medical Group, Inc.

Indianapolis, Indiana, United States

Genesis Medical Center

Davenport, Iowa, United States

Mercy Hospital Medical Center

Des Moines, Iowa, United States

Kings Daughters Medical Center

Ashland, Kentucky, United States

Maine Medical Center

Portland, Maine, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

Tufts Medical Center, Inc.

Boston, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Northern Michigan Hospital

Petoskey, Michigan, United States

St Mary's Duluth Clinic

Duluth, Minnesota, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Our Lady of Lourdes Medical Center

Haddon Heights, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

New Mexico Heart Institute, PA

Albuquerque, New Mexico, United States

Mount Sinai - PRIME

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

New York Presbyterian Hospital

New York, New York, United States

Moses H. Cone Memorial Hospital-LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, United States

Rex Hospital

Raleigh, North Carolina, United States

Wake Heart Research, LLC

Raleigh, North Carolina, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Lindner Center for Research and Education at Christ Hosp

Cincinnati, Ohio, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Mercy St. Vincent Medical Center

Toledo, Ohio, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Providence Portland Medical Center

Portland, Oregon, United States

Geisinger Clinic

Danville, Pennsylvania, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Sisters of Charity Providence Hospitals

Columbia, South Carolina, United States

Jackson Madison County Hospital

Jackson, Tennessee, United States

Centennial Medical Center

Nashville, Tennessee, United States

Baylor Heart & Vascular Hospital

Dallas, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

St. David's Round Rock Medical Center

Round Rock, Texas, United States

Methodist Texsan Hospital

San Antonio, Texas, United States

Henrico Doctors Hospital

Richmond, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Aspirus Heart & Vascular Institute

Wausau, Wisconsin, United States

The Prince Charles Hospital

Chermside, Queensland, Australia

Monash Medical Centre-Clayton Campus

Clayton, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Fremantle Hospital

Fremantle, Western Australia, Australia

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, , Austria

AKH - Medizinische Universität Wien

Vienna, , Austria

Imelda Ziekenhuis

Bonheiden, , Belgium

Z.O.L - Campus St. Jan

Genk, , Belgium

UZ Leuven

Leuven, , Belgium

HHrm

Roeselare, , Belgium

Foothills Medical Centre

Calgary, Alberta, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Institut de Cardiologie de Montreal

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Sainte-Foy, Quebec, Canada

Rigshospitalet Copenhagen

Copenhagen, , Denmark

University Hospital, Heart Centre

Tampere, , Finland

Turku University Hospital

Turku, , Finland

CHU de Brest - Hôpital de la Cavale Blanche

Brest, Finistere, France

CHU de Toulouse - Hôpital Rangueil

Toulouse, Haute Garonne, France

Clinique Pasteur - Toulouse

Toulouse, Haute Garonne, France

Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

Bron, Rhone, France

Clinique Saint-Hilaire - Centre Frédéric Joliot

Rouen, Seine Maritime, France

Polyclinique Les Fleurs

Ollioules, Var, France

Centre Hospitalier de Lagny - Marne La Vallée

Lagny-sur-Marne, , France

Hôpital Cochin

Paris, , France

Istituto Clinico Humanitas

Rozzano, Milano, Italy

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

Roma, , Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, , Italy

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

National Cerebral and Cardiovascular Center

Suita-shi, Osaka, Japan

Teikyo University Hospital

Itabashi-ku, Tokyo-To, Japan

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo-To, Japan

Toho University Ohashi Medical Center

Meguro-ku, Tokyo-To, Japan

The Cardiovascular Institute

Minatoku, Tokyo-To, Japan

Showa University Hospital

Shinagawa-ku, Tokyo-To, Japan

Department of Cardiology, Tokyo Women's Medical University

Shinjuku-ku, Tokyo-To, Japan

P. Stradins Clinical University Hospital

Riga, , Latvia

Medisch Centrum Alkmaar

Alkmaar, , Netherlands

Medisch Spectrum Twente, Haaksbergerstraat

Enschede, , Netherlands

St. Antonius Ziekenhuis, Nieuwegein

Nieuwegein, , Netherlands

Ascot Angiography Ltd

Auckland, , New Zealand

Middlemore Hospital

Auckland, , New Zealand

North Shore Hospital

Auckland, , New Zealand

Christchurch Hospital NZ

Christchurch, , New Zealand

SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, , Poland

SK Przemienienia Panskiego UM im.K.Marcinkowskiego

Poznan, , Poland

Instytut Kardiologii im.Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

Warsaw, , Poland

National University Hospital

Singapore, , Singapore

National Heart Centre

Singapore, , Singapore

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Countries

United States; Australia; Austria; Belgium; Canada; Denmark; Finland; France; Italy; Japan; Latvia; Netherlands; New Zealand; Poland; Singapore; Spain

References

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.

Reference Type: DERIVED

PMID: 31451014 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25855680 (View on PubMed)

Other Identifiers

G120123

Identifier Type: OTHER

Identifier Source: secondary_id

S2067

Identifier Type: -

Identifier Source: org_study_id