Clinical trial NCT01665053: The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Drug-Eluting Stents
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-08-15
Enrollment: 1684
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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)

Primary outcomes:
measure: Percentage of Participants With Target Lesion Failure (TLF) at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.
timeFrame: 12 months
measure: Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.
timeFrame: 12 months
measure: Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.
timeFrame: 12 months
measure: Percentage of Participants With Myocardial Infarction at 12 Month.
timeFrame: 12 months
measure: Percentage of Participants With Cardiac Death at 12 Month.
timeFrame: 12 months
measure: Percentage of Participants With Non-Cardiac Death at 12 Month.
timeFrame: 12 months
measure: Percentage of Patients That Died at 12 Months.
timeFrame: 12 months
measure: Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.
timeFrame: 12 months
measure: Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.
timeFrame: 12 months
measure: Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.
timeFrame: 12 months
measure: Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.
timeFrame: 12 months
measure: Percentage of Patients With a Stroke at 12 Month.
timeFrame: 12 months
measure: Periprocedural Technical Success Rate.
timeFrame: Day 1 (periprocedure)
measure: Periprocedural Clinical Procedural Success Rate
timeFrame: Day 1 (periprocedure)
measure: Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.
timeFrame: 12 month
measure: Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.
timeFrame: 12 Month
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center - Princeton
state: Alabama
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Memorial Hospital
state: California
city: Sacramento
country: United States
facility: University of California Davis Health System
state: California
city: Sacramento
country: United States
facility: Sutter Memorial Hospital
state: California
city: San Diego
country: United States
facility: Alvarado Hospital Medical Center
state: California
city: Greeley
country: United States
facility: North Colorado Medical Center
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology Associates, PC
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Mease Healthcare
state: Florida
city: Miami
country: United States
facility: University of Miami McKnight Brain Institute
state: Florida
city: Ocala
country: United States
facility: MediQuest
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute, Inc.
state: Florida
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Marietta
country: United States
facility: Wellstar Health Systems
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Foundation Hospital
state: Hawaii
city: Coeur d'Alene
country: United States
facility: Kootenai Medical Center
state: Idaho
city: Springfield
country: United States
facility: Prairie Cardiovascular Consultants, Ltd.
state: Illinois
city: Fort Wayne
country: United States
facility: Northern Indiana Research Alliance
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent's Medical Group, Inc.
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Ashland
country: United States
facility: Kings Daughters Medical Center
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center, Inc.
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Medical Center - Burlington
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Duluth
country: United States
facility: St Mary's Duluth Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Haddon Heights
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute, PA
state: New Mexico
city: New York
country: United States
facility: Mount Sinai - PRIME
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital-LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart Research, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Center for Research and Education at Christ Hosp
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Sisters of Charity Providence Hospitals
state: South Carolina
city: Jackson
country: United States
facility: Jackson Madison County Hospital
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hospital
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Round Rock
country: United States
facility: St. David's Round Rock Medical Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Texsan Hospital
state: Texas
city: Richmond
country: United States
facility: Henrico Doctors Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Wausau
country: United States
facility: Aspirus Heart & Vascular Institute
state: Wisconsin
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Medical Centre-Clayton Campus
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: Vienna
country: Austria
facility: AKH - Medizinische Universität Wien
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Genk
country: Belgium
facility: Z.O.L - Campus St. Jan
city: Leuven
country: Belgium
facility: UZ Leuven
city: Roeselare
country: Belgium
facility: HHrm
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
state: Quebec
city: Sainte-Foy
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
state: Quebec
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Tampere
country: Finland
facility: University Hospital, Heart Centre
city: Turku
country: Finland
facility: Turku University Hospital
city: Brest Cedex 2
country: France
facility: CHU de Brest - Hôpital de la Cavale Blanche
state: Finistere
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Rangueil
state: Haute Garonne
city: Toulouse
country: France
facility: Clinique Pasteur - Toulouse
state: Haute Garonne
city: Bron
country: France
facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
state: Rhone
city: Rouen
country: France
facility: Clinique Saint-Hilaire - Centre Frédéric Joliot
state: Seine Maritime
city: Ollioules
country: France
facility: Polyclinique Les Fleurs
state: Var
city: Lagny-sur-Marne cedex
country: France
facility: Centre Hospitalier de Lagny - Marne La Vallée
city: Paris
country: France
facility: Hôpital Cochin
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Roma
country: Italy
facility: Umberto I Pol. di Roma-Università di Roma La Sapienza
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Kitakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka-Ken
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka-Ken
city: Yokohama-shi
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
state: Kanagawa-Ken
city: Kamakura-shi
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital
state: Kyoto-Fu
city: Suita-shi
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka-Fu
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo-To
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo-To
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo-To
city: Minato-ku
country: Japan
facility: The Cardiovascular Institute
state: Tokyo-To
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: Department of Cardiology, Tokyo Women's Medical University
state: Tokyo-To
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente, Haaksbergerstraat
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis, Nieuwegein
city: Auckland
country: New Zealand
facility: Ascot Angiography Ltd
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital NZ
city: Krakow
country: Poland
facility: SPZOZ Szpital Uniwersytecki w Krakowie
city: Poznan
country: Poland
facility: SK Przemienienia Panskiego UM im.K.Marcinkowskiego
city: Warszawa
country: Poland
facility: Instytut Kardiologii im.Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Heart Centre
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Boston Scientific Corporation
name: Peter M Maurer, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.