OPTIMIZE IDE for the Treatment of ACS



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:January 2, 2018
End Date:June 28, 2024
Contact:Betsy Lowry
Email:blowry@sveltemedical.com
Phone:908-264-2181

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The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study

Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in
patients with symptomatic heart disease, including patients with non-ST elevation MI due to
discrete de novo native coronary artery lesions. The treated lesion length should be less
than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm


Inclusion Criteria:

- Subject is an eligible candidate 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 has up to 3 de novo target lesions in up to 2 native coronary artery vessels,
with no more than 2 lesions in a single vessel, each meeting the angiographic criteria
and none of the exclusion criteria.

- Target lesion(s) must be located in a native coronary artery with a visually estimated
reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 4.00 mm;

Exclusion Criteria:

- The subject has cardiogenic shock, hemodynamic instability requiring inotropic or
mechanical circulatory support, intractable ventricular arrhythmias, or ongoing
intractable angina;

- The subject's target lesion(s) is located in the left main artery;

- The subject's 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;

- The subject's target lesion(s) is located within a saphenous vein graft or arterial
graft;

- The subject's target lesion(s) will be accessed via a saphenous vein graft or arterial
graft;
We found this trial at
60
sites
Ocala, Florida 34471
Principal Investigator: Robert Feldman, MD
Phone: 352-351-7337
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Natalia Berry, MD
Phone: 617-732-7381
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Sammy Elmariah, MD
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Giora Weisz, MD
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Miami, Florida 33136
Principal Investigator: Mauricio Cohen, MD
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Miami, FL
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Principal Investigator: Nainesh Patel, MD
Phone: 610-402-9005
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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Allentown, PA
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Bakersfield, California 93301
Principal Investigator: Tommy Lee, MD
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Bakersfield, CA
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Baltimore, Maryland
Principal Investigator: John Wang, MD
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Baltimore, MD
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Browns Mills, New Jersey 08015
Principal Investigator: Richard Kovach, MD
Phone: 609-893-1200
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Charlottesville, Virginia 22908
Principal Investigator: Michael Ragosta, MD
Phone: 434-982-1058
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Charlottesville, VA
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Sandeep Nathan, MD
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, Illinois 60612
Principal Investigator: Mladen Vidovich, MD
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Dean Kereiakes, MD
Phone: 513-585-1777
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Cincinnati, OH
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Clearwater, Florida 33756
Principal Investigator: Bernardo Stein, MD
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Clearwater, FL
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Clearwater, Florida 33756
Principal Investigator: Masood Gilani, MD
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Principal Investigator: Arash Arshi, MD
Phone: 614-566-5768
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Des Moines, Iowa 50314
Principal Investigator: Magdi Ghali, MD
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Duluth, Minnesota 55805
Principal Investigator: Kalkidan Bishu, MD
Phone: 218-786-2077
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508 Fulton Street
Durham, North Carolina 27705
919-286-0411
Principal Investigator: Sunil Rao, MD
Durham VA Medical Center Since 1953, Durham Veterans Affairs Medical Cetner has been improving the...
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Elkhart, Indiana 46514
Principal Investigator: Donald Westerhausen, MD
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Fairhope, Alabama 36532
Principal Investigator: David Trice, MD
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Fremont, California 94538
Principal Investigator: Ashit Jain, MD
Phone: 510-796-0222
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Greensboro, North Carolina
Principal Investigator: Muhammad Arida, MD
Phone: 336-832-3795
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Greenville, South Carolina 29605
Principal Investigator: Jesse Jorgensen, MD
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Hershey, Pennsylvania 17033
Principal Investigator: Ian Gilchrist, MD
Phone: 717-531-1452
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120 North Oak Street
Hinsdale, Illinois 60521
Principal Investigator: Edgar Carell, MD
Phone: 630-528-4370
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Hollywood, Florida 33021
Principal Investigator: Jonathan Roberts, MD
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Hollywood, FL
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Houston, Texas 77030
Principal Investigator: Colin Barker, MD
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Houston, TX
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Houston, Texas 77225
Principal Investigator: Emerson Perin, MD
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Indianapolis, Indiana 46260
Principal Investigator: Andrew Fouts, MD
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Indianapolis, IN
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Kalamazoo, Michigan 49008
Principal Investigator: Vishal Gupta, MD
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Kamakura, 247-0072
Principal Investigator: Shigeru Saito, MD
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Kansas City, Missouri 64111
Principal Investigator: Anthony Hart, MD
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Little Rock, Arkansas 72211
Principal Investigator: David Mego, MD
Phone: 501-748-8421
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Little Rock, AR
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Long Beach, California 90822
Principal Investigator: Arnold Seto, MD
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Los Angeles, California 90033
Principal Investigator: Ray Matthews, MD
Phone: 323-442-7983
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Marietta, Georgia 30106
Principal Investigator: Amar Patel, MD
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Marietta, GA
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259 1st Street
Mineola, New York 11501
Principal Investigator: Ramesh Daggubati, MD
Phone: 516-663-8692
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Morristown, New Jersey 07962
Principal Investigator: Jordan Safirstein, MD
Phone: 973-713-4145
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New York, New York 10003
Principal Investigator: Yumiko Kanei, MD
Phone: 212-844-6301
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New York, New York 10016
Principal Investigator: John Coppola, MD
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New York, New York 10065
Principal Investigator: Shing C Wong, MD
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Newark, Delaware 19718
Principal Investigator: Neil Wimmer, MD
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Principal Investigator: Mark East, MD
Phone: 757-388-3529
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Petoskey, Michigan 49770
Principal Investigator: Thomas Earl, MD
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Raleigh, North Carolina 27607
Principal Investigator: James Zidar, MD
Phone: 919-784-3795
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Rochester, Minnesota 55905
Principal Investigator: David Holmes, MD
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Rochester, New York 14621
Principal Investigator: Jeremiah Depta, MD
Phone: 585-922-3536
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2410 Round Rock Avenue
Round Rock, Texas 78681
Principal Investigator: Craig Siegel, MD
Phone: 513-341-0889
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Royal Oak, Michigan 48073
Principal Investigator: Amr Abbas, MD
Phone: 248-898-5580
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Marc Sintek, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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1100 McCullough Avenue
San Antonio, Texas 78212
Principal Investigator: Jose Perez, MD
Phone: 210-635-1690
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San Francisco, California 94121
Principal Investigator: Kendrick Shunk, MD
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Sayre, Pennsylvania 18840
Principal Investigator: Edo Kaluski, MD
Phone: 570-887-6071
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Scarborough, Maine 04074
Principal Investigator: William Dietz, MD
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Scottsdale, Arizona 85259
Principal Investigator: David Rizik, MD
Phone: 480-225-3757
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Seattle, Washington 98122
Principal Investigator: John Petersen, MD
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Syracuse, New York 13203
Principal Investigator: Ronald Caputo, MD
Phone: 315-634-6693
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Tallahassee, Florida 32308
Principal Investigator: Wayne Batchelor, MD
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Tupelo, Mississippi 38801
Principal Investigator: Barry Bertolet, MD
Phone: 662-377-7456
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