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



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:November 2012
End Date:December 22, 2018

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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).

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.

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)
We found this trial at
70
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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777 Hemlock Street
Macon, Georgia 31201
(478) 633-1000
Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Albuquerque, New Mexico 87102
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Ashland, Kentucky 41101
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Bakersfield, California 93301
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Baltimore, Maryland 21218
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Birmingham, Alabama 35211
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Browns Mills, New Jersey 08015
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Burlington, Massachusetts 01805
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Chermside, Queensland 4032
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Clearwater, Florida 33756
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Coeur d'Alene, Idaho 83814
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Columbia, South Carolina 29204
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Danville, Pennsylvania 17882
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Davenport, Iowa 52803
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Des Moines, Iowa 50314
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Detroit, Michigan 48202
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Duluth, Minnesota 55805
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Fort Wayne, Indiana 46804
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1 Genesys Pkwy
Grand Blanc, Michigan 48439
(810) 606-5000
Genesys Regional Medical Center Genesys Health System, a member of Ascension Health, is a group...
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1801 16th St
Greeley, Colorado 80631
(970) 352-4121
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Haddon Heights, New Jersey 08035
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Honolulu, Hawaii 96817
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Indianapolis, Indiana 46290
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Jackson, Tennessee 38301
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Little Rock, Arkansas 72211
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Littleton, Colorado 80120
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Marietta, Georgia 30060
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Morristown, New Jersey 07962
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Nashville, Tennessee 37203
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New York, New York 10029
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, New York 10032
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Ocala, Florida 34471
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Oklahoma City, Oklahoma 73120
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Orlando, Florida 32803
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Petoskey, Michigan 49770
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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800 Spruce St
Philadelphia, Pennsylvania 19107
215-829-3000
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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Phoenix, Arizona 85006
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Raleigh, North Carolina 27607
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Raleigh, North Carolina 27610
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Richmond, Virginia 23294
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Round Rock, Texas 78681
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Sacramento, California 95815
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Antonio, Texas 78201
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San Diego, California 92121
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Springfield, Illinois 62701
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Tallahassee, Florida 32308
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Tupelo, Mississippi 38801
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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Wausau, Wisconsin 54401
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Winston-Salem, North Carolina 27157
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