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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01665053
First received: August 7, 2012
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Device: PROMUS Element Plus
Device: SYNERGY
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Target Lesion Failure (TLF) Rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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:
  • Target Lesion Revascularization (TLR) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: No ]
  • Target Lesion Failure (TLF) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: No ]
  • All Revascularization Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: No ]
  • Target Vessel Failure (TVF) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI, Q-wave and non-Q-wave) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Non-Cardiac Death Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • All Death Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death or Myocardial Infarction (MI) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • All Death or Myocardial Infarction (MI) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • All Death, Myocardial Infarction (MI) or Target Vessel Revascularization (TVR) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis Rate by Academic Research Consortium (ARC) Definition [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Stroke Rate (ischemic and hemorrhagic) [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Technical Success Rate [ Time Frame: Day 1 (periprocedure) ] [ Designated as safety issue: No ]
  • Clinical Procedural Success Rate [ Time Frame: Day 1 (periprocedure) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2009
Study Start Date: November 2012
Estimated Study Completion Date: August 2018
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Device: PROMUS Element Plus
Experimental: 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).
Device: SYNERGY

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

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)

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665053

  Hide Study Locations
Locations
United States, Alabama
Baptist Medical Center - Princeton
Birmingham, Alabama, United States, 35211
United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, California
Bakersfield Memorial Hospital
Bakersfield, California, United States, 93301
University of California Davis Health System
Sacramento, California, United States, 95617
Sutter Memorial Hospital
Sacramento, California, United States, 95819
Alvarado Hospital Medical Center
San Diego, California, United States, 92121
United States, Colorado
North Colorado Medical Center
Greeley, Colorado, United States, 80631
South Denver Cardiology Associates, PC
Littleton, Colorado, United States, 80120
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Morton Plant Mease Healthcare
Clearwater, Florida, United States, 33756
University of Miami McKnight Brain Institute
Miami, Florida, United States, 33138
MediQuest
Ocala, Florida, United States, 34471
Florida Hospital Medical Center
Orlando, Florida, United States, 32803
Tallahassee Research Institute, Inc.
Tallahassee, Florida, United States, 32308
United States, Georgia
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
Wellstar Health Systems
Marietta, Georgia, United States, 30060
United States, Hawaii
Kaiser Foundation Hospital
Honolulu, Hawaii, United States, 96819
United States, Idaho
Kootenai Medical Center
Coeur D'Alene, Idaho, United States, 83814
United States, Illinois
Prairie Cardiovascular Consultants, Ltd.
Springfield, Illinois, United States, 62701
United States, Indiana
Northern Indiana Research Alliance
Fort Wayne, Indiana, United States, 46804
St. Vincent's Medical Group, Inc.
Indianapolis, Indiana, United States, 46290
United States, Iowa
Genesis Medical Center
Davenport, Iowa, United States, 52803
Mercy Hospital Medical Center
Des Moines, Iowa, United States, 50314
United States, Kentucky
Kings Daughters Medical Center
Ashland, Kentucky, United States, 41101
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
MedStar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
United States, Massachusetts
Tufts Medical Center, Inc.
Boston, Massachusetts, United States, 02110
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02120
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States, 01805
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
United States, Minnesota
St Mary's Duluth Clinic
Duluth, Minnesota, United States, 55805
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Mississippi
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
United States, Missouri
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
Our Lady of Lourdes Medical Center
Haddon Heights, New Jersey, United States, 08035
Morristown Medical Center
Morristown, New Jersey, United States, 07960
United States, New Mexico
New Mexico Heart Institute, PA
Albuquerque, New Mexico, United States, 87042
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10065
Mount Sinai - PRIME
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Moses H. Cone Memorial Hospital-LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States, 27401
Wake Heart Research, LLC
Raleigh, North Carolina, United States, 27610
Rex Hospital
Raleigh, North Carolina, United States, 27607
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Lindner Center for Research and Education at Christ Hosp
Cincinnati, Ohio, United States, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44103
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Mercy St. Vincent Medical Center
Toledo, Ohio, United States, 43608
United States, Oklahoma
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Geisinger Clinic
Danville, Pennsylvania, United States, 17822
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Sisters of Charity Providence Hospitals
Columbia, South Carolina, United States, 29204
United States, Tennessee
Jackson Madison County Hospital
Jackson, Tennessee, United States, 38301
Centennial Medical Center
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Heart & Vascular Hospital
Dallas, Texas, United States, 75226
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
St. David's Round Rock Medical Center
Round Rock, Texas, United States, 78681
Methodist Texsan Hospital
San Antonio, Texas, United States, 78201
United States, Virginia
Henrico Doctors Hospital
Richmond, Virginia, United States, 23229
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
United States, Wisconsin
Aspirus Heart & Vascular Institute
Wausau, Wisconsin, United States, 54401
Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, Victoria
Monash Medical Centre-Clayton Campus
Clayton, Victoria, Australia, 3168
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria
AKH - Medizinische Universität Wien
Vienna, Austria
Belgium
Imelda Ziekenhuis
Bonheiden, Belgium, 2820
Z.O.L - Campus St. Jan
Genk, Belgium, 3600
UZ Leuven
Leuven, Belgium, 3000
HHrm
Roeselare, Belgium, 8800
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M4
Canada, Quebec
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada, H1T 1C8
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Sainte-Foy, Quebec, Canada, G1V 4G5
Denmark
Rigshospitalet Copenhagen
Copenhagen, Denmark, 2100
Finland
University Hospital, Heart Centre
Tampere, Finland, 33521
Turku University Hospital
Turku, Finland, FI-20520
France
CHU de Brest - Hôpital de la Cavale Blanche
Brest Cedex 2, Finistere, France, 29609
Clinique Pasteur - Toulouse
Toulouse, Haute Garonne, France, 31076
CHU de Toulouse - Hôpital Rangueil
Toulouse, Haute Garonne, France, 31059
Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
Bron, Rhone, France, 69500
Clinique Saint-Hilaire - Centre Frédéric Joliot
Rouen, Seine Maritime, France, 76000
Polyclinique Les Fleurs
Ollioules, Var, France, 83192
Centre Hospitalier de Lagny - Marne La Vallée
Lagny-sur-Marne cedex, France, 77600
Hôpital Cochin
Paris, France, 75014
Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Umberto I Pol. di Roma-Università di Roma La Sapienza
Roma, Italy, 161
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy, 10126
Japan
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka-Ken, Japan, 802-8555
Kurume University Hospital
Kurume-shi, Fukuoka-Ken, Japan, 830-0011
Saiseikai Yokohamashi Tobu Hospital
Yokohama-shi, Kanagawa-Ken, Japan, 230-8765
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, Japan, 247-8533
Kyoto University Hospital
Kyoto-shi, Kyoto-Fu, Japan, 606-8507
National Cerebral and Cardiovascular Center
Suita-shi, Osaka-Fu, Japan, 565-8565
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo-To, Japan, 173-8610
Teikyo University Hospital
Itabashi-ku, Tokyo-To, Japan, 173-8606
Toho University Ohashi Medical Center
Meguro-ku, Tokyo-To, Japan, 153-8515
The Cardiovascular Institute
Minato-ku, Tokyo-To, Japan, 106-0031
Showa University Hospital
Shinagawa-ku, Tokyo-To, Japan, 142-8666
Department of Cardiology, Tokyo Women's Medical University
Shinjuku-ku, Tokyo-To, Japan, 162-8666
Latvia
P. Stradins Clinical University Hospital
Riga, Latvia, LV1002
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1815 JD
Medisch Spectrum Twente, Haaksbergerstraat
Enschede, Netherlands, 7513 ER
St. Antonius Ziekenhuis, Nieuwegein
Nieuwegein, Netherlands, 3435CM
New Zealand
Ascot Angiography Ltd
Auckland, New Zealand, 1050
North Shore Hospital
Auckland, New Zealand, 622
Middlemore Hospital
Auckland, New Zealand, 1640
Christchurch Hospital NZ
Christchurch, New Zealand, 8011
Poland
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland, 31-501
SK Przemienienia Panskiego UM im.K.Marcinkowskiego
Poznan, Poland, 61-848
Instytut Kardiologii im.Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego
Warszawa, Poland, 04-628
Singapore
National Heart Centre
Singapore, Singapore, 168752
National University Hospital
Singapore, Singapore, 119228
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 8036
Hospital Universitario Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Peter M Maurer, MPH Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01665053     History of Changes
Other Study ID Numbers: S2067, G120123
Study First Received: August 7, 2012
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Drug-Eluting Stents

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014