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 |
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
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
3535 Olentangy River Rd
Columbus, Ohio 43214
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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75 Francis street
Boston, Massachusetts 02115
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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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Sammy Elmariah, MD
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3550 Jerome Avenue
Bronx, New York 10467
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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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
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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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
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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2139 Auburn Ave
Cincinnati, Ohio 45219
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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Clearwater, Florida 33756
Principal Investigator: Bernardo Stein, 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
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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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
Hinsdale, Illinois 60521
Principal Investigator: Edgar Carell, MD
Phone: 630-528-4370
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Indianapolis, Indiana 46260
Principal Investigator: Andrew Fouts, MD
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Little Rock, Arkansas 72211
Principal Investigator: David Mego, MD
Phone: 501-748-8421
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Los Angeles, California 90033
Principal Investigator: Ray Matthews, MD
Phone: 323-442-7983
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259 1st Street
Mineola, New York 11501
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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600 Gresham Dr
Norfolk, Virginia 23507
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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Raleigh, North Carolina 27607
Principal Investigator: James Zidar, MD
Phone: 919-784-3795
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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
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
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
San Antonio, Texas 78212
Principal Investigator: Jose Perez, MD
Phone: 210-635-1690
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Sayre, Pennsylvania 18840
Principal Investigator: Edo Kaluski, MD
Phone: 570-887-6071
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Scottsdale, Arizona 85259
Principal Investigator: David Rizik, MD
Phone: 480-225-3757
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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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