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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665053
• Other study ID #: S2067
• Secondary ID: G120123
• Status: Completed
• Phase: Phase 3
• Start date: November 2012
• Est. completion date: December 22, 2018

Study information

• Verified date: January 2019
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 1684
• Est. completion date: December 22, 2018
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• PROMUS Element Plus
A drug eluting coronary stent system
• SYNERGY
A drug eluting coronary stent system

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.	The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) & TLR Coronary Artery Bypass Graft (CABG).	12 months
Secondary	Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.	TVR overall includes: TVR PCI & TVR CABG.	12 months
Secondary	Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.	Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.	12 months
Secondary	Percentage of Participants With Myocardial Infarction at 12 Month.	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.	12 months
Secondary	Percentage of Participants With Cardiac Death at 12 Month.		12 months
Secondary	Percentage of Participants With Non-Cardiac Death at 12 Month.		12 months
Secondary	Percentage of Patients That Died at 12 Months.	The Death rate includes Cardiac- & Non-Cardiac Death.	12 months
Secondary	Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.		12 months
Secondary	Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.		12 months
Secondary	Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.		12 months
Secondary	Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.		12 months
Secondary	Percentage of Patients With a Stroke at 12 Month.	The stroke rate includes: Ischemic- , Hemorraghic- & Undetermined Stroke.	12 months
Secondary	Periprocedural Technical Success Rate.	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.	Day 1 (periprocedure)
Secondary	Periprocedural Clinical Procedural Success Rate	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.	Day 1 (periprocedure)
Secondary	Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.		12 month
Secondary	Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.	All CEC adjudicated revascularization at 12 month (Intent to treat population).	12 Month