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

Use our guide to learn which trials are right for you!

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
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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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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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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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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Des Moines, IA
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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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Durham, NC
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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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Greensboro, NC
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Greenville, South Carolina 29605
Principal Investigator: Jesse Jorgensen, MD
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Greenville, SC
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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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Kalamazoo, MI
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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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Ocala, Florida 34471
Principal Investigator: Robert Feldman, MD
Phone: 352-351-7337
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Petoskey, Michigan 49770
Principal Investigator: Thomas Earl, MD
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Petoskey, MI
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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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