The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
- Conditions
- Coronary Artery Disease
- Interventions
- Device: PROMUS Element PlusDevice: SYNERGY
- Registration Number
- NCT01665053
- Lead Sponsor
- Boston Scientific Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1684
- 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
Angiographic Inclusion Criteria (visual estimate):
- 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
-
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)
Angiographic Exclusion Criteria (visual estimate):
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Promus Element Plus 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). SYNERGY 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).
- Primary Outcome Measures
Name Time Method Percentage of Participants With Target Lesion Failure (TLF) at 12 Months 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Cardiac Death at 12 Month. 12 months Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month. 12 months Percentage of Participants With Target Vessel Failure (TVF) at 12 Month. 12 months Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.
Percentage of Participants With Myocardial Infarction at 12 Month. 12 months The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.
Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month. 12 months Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month. 12 Month All CEC adjudicated revascularization at 12 month (Intent to treat population).
Percentage of Patients That Died at 12 Months. 12 months The Death rate includes Cardiac- \& Non-Cardiac Death.
Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months. 12 months The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) \& TLR Coronary Artery Bypass Graft (CABG).
Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months. 12 months TVR overall includes: TVR PCI \& TVR CABG.
Percentage of Participants With Non-Cardiac Death at 12 Month. 12 months Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month. 12 months Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month. 12 months Percentage of Patients With a Stroke at 12 Month. 12 months The stroke rate includes: Ischemic- , Hemorraghic- \& Undetermined Stroke.
Periprocedural Technical Success Rate. Day 1 (periprocedure) Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.
Periprocedural Clinical Procedural Success Rate Day 1 (periprocedure) Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.
Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month. 12 month
Trial Locations
- Locations (126)
Rex Hospital
🇺🇸Raleigh, North Carolina, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
MedStar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Lahey Clinic Medical Center - Burlington
🇺🇸Burlington, Massachusetts, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
University of California Davis Health System
🇺🇸Sacramento, California, United States
Bakersfield Memorial Hospital
🇺🇸Bakersfield, California, United States
South Denver Cardiology Associates, PC
🇺🇸Littleton, Colorado, United States
Morton Plant Mease Healthcare
🇺🇸Clearwater, Florida, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, 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
Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Mercy Hospital Medical Center
🇺🇸Des Moines, Iowa, United States
Kings Daughters Medical Center
🇺🇸Ashland, Kentucky, 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
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, 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
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
Wake Heart Research, LLC
🇺🇸Raleigh, North Carolina, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, 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
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
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
Henrico Doctors Hospital
🇺🇸Richmond, Virginia, 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
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
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
HHrm
🇧🇪Roeselare, Belgium
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
🇨🇦Sainte-Foy, Quebec, Canada
Institut de Cardiologie de Montreal
🇨🇦Montreal, Quebec, Canada
University Hospital, Heart Centre
🇫🇮Tampere, Finland
Rigshospitalet Copenhagen
🇩🇰Copenhagen, Denmark
Turku University Hospital
🇫🇮Turku, Finland
CHU de Brest - Hôpital de la Cavale Blanche
🇫🇷Brest Cedex 2, 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 cedex, France
Hôpital Cochin
🇫🇷Paris, France
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Umberto I Pol. di Roma-Università di Roma La Sapienza
🇮🇹Roma, Italy
Shonan Kamakura General Hospital
🇯🇵Kamakura-shi, Kanagawa, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Fukuoka-Ken, Japan
Saiseikai Yokohamashi Tobu Hospital
🇯🇵Yokohama-shi, Kanagawa-Ken, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu-shi, Fukuoka-Ken, Japan
Kyoto University Hospital
🇯🇵Kyoto-shi, Kyoto-Fu, Japan
The Cardiovascular Institute
🇯🇵Minato-ku, Tokyo-To, Japan
National Cerebral and Cardiovascular Center
🇯🇵Suita-shi, Osaka-Fu, Japan
Nihon University Itabashi Hospital
🇯🇵Itabashi-ku, Tokyo-To, Japan
Teikyo University Hospital
🇯🇵Itabashi-ku, Tokyo-To, Japan
Toho University Ohashi Medical Center
🇯🇵Meguro-ku, Tokyo-To, Japan
Showa University Hospital
🇯🇵Shinagawa-ku, Tokyo-To, Japan
Department of Cardiology, Tokyo Women's Medical University
🇯🇵Shinjuku-ku, Tokyo-To, Japan
Medisch Centrum Alkmaar
🇳🇱Alkmaar, Netherlands
St. Antonius Ziekenhuis, Nieuwegein
🇳🇱Nieuwegein, Netherlands
Middlemore Hospital
🇳🇿Auckland, New Zealand
North Shore Hospital
🇳🇿Auckland, New Zealand
Medisch Spectrum Twente, Haaksbergerstraat
🇳🇱Enschede, Netherlands
SK Przemienienia Panskiego UM im.K.Marcinkowskiego
🇵🇱Poznan, Poland
Ascot Angiography Ltd
🇳🇿Auckland, New Zealand
Christchurch Hospital NZ
🇳🇿Christchurch, New Zealand
SPZOZ Szpital Uniwersytecki w Krakowie
🇵🇱Krakow, 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
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
Swedish Medical Center
🇺🇸Seattle, Washington, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
P. Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Instytut Kardiologii im.Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego
🇵🇱Warszawa, Poland
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Lindner Center for Research and Education at Christ Hosp
🇺🇸Cincinnati, Ohio, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Baptist Medical Center - Princeton
🇺🇸Birmingham, Alabama, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
Alvarado Hospital Medical Center
🇺🇸San Diego, California, United States
University of Miami McKnight Brain Institute
🇺🇸Miami, Florida, United States
St. Vincent's Medical Group, Inc.
🇺🇸Indianapolis, Indiana, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Methodist Texsan Hospital
🇺🇸San Antonio, Texas, United States
Sutter Memorial Hospital
🇺🇸Sacramento, California, United States
New Mexico Heart Institute, PA
🇺🇸Albuquerque, New Mexico, United States