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

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)

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: PROMUS Element Plus; 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.

• Study Type: Interventional
• Enrollment (Actual): 1684
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; A drug eluting coronary stent system
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; A drug eluting coronary stent system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.	TVR overall includes: TVR PCI & TVR CABG.	12 months
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
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
Percentage of Participants With Cardiac Death at 12 Month.		12 months
Percentage of Participants With Non-Cardiac Death at 12 Month.		12 months
Percentage of Patients That Died at 12 Months.	The Death rate includes Cardiac- & Non-Cardiac Death.	12 months
Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.		12 months
Percentage of Participants Who Died or Had an 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 Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.		12 months
Percentage of Patients With a Stroke at 12 Month.	The stroke rate includes: Ischemic- , Hemorraghic- & Undetermined Stroke.	12 months
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)
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)
Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.		12 month
Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.	All CEC adjudicated revascularization at 12 month (Intent to treat population).	12 Month

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): December 22, 2018

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 15, 2012

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Drug-Eluting Stents
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: S2067; G120123 (Other Identifier: FDA)