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Company financial insolvency, not due to safety or efficacy concerns
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Svelte | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DES | Device | PCI with implantation of a DES |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure (TVF) | 6 and 12 months, and annually through 5 years | |
| Major Adverse Cardiac Event (MACE) | 6 and 12 months and annually through 5 years follow-up | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shing C Wong, MD | Svelte Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Hospital | Fairhope | Alabama | 36532 | United States | ||
| Scottsdale Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34353122 | Derived | Kereiakes DJ, Feldman RL, Ijsselmuiden AJJ, Saito S, Amoroso G, Zidar JP, Wong SC, Stella P, Yakubov S, Lasala J, Cohen DJ, Doros G, Cutlip DE, Rao SV. Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study. Circ Cardiovasc Interv. 2021 Sep;14(9):e010609. doi: 10.1161/CIRCINTERVENTIONS.121.010609. Epub 2021 Aug 6. | |
| 31415994 |
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| Stent Thrombosis |
| 6 and 12 months and annually through 5 years follow-up |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Bakersfield Memorial Hospital | Bakersfield | California | 93301 | United States |
| Mission Cardiovascular Research Institute (Washington Hospital) | Fremont | California | 94538 | United States |
| Long Beach VA Medical Center | Long Beach | California | 90822 | United States |
| Keck Hospital of USC | Los Angeles | California | 90033 | United States |
| San Francisco VA | San Francisco | California | 94121 | United States |
| Christiana Hospital | Newark | Delaware | 19702 | United States |
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States |
| Clearwater Cardiovascular Consultants | Clearwater | Florida | 34695 | United States |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| University of Miami Medical Center | Miami | Florida | 33125 | United States |
| Mediquest (Munroe Regional Medical Center) | Ocala | Florida | 34471 | United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32303 | United States |
| Jesse Brown VAMC | Chicago | Illinois | 60637 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Amita/Adventist Heart and Vascular | Hinsdale | Illinois | 60521 | United States |
| Elkhart General Healthcare | Elkhart | Indiana | 46514 | United States |
| St Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290 | United States |
| Mercy Hospital Medical Center | Des Moines | Iowa | 50314 | United States |
| Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Borgess Heart Center | Kalamazoo | Michigan | 49008 | United States |
| Northern Michigan Hospital d.b.a McLaren Northern Michigan | Petoskey | Michigan | 49770 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| St. Mary's Duluth Clinic | Duluth | Minnesota | 55805 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| North Mississippi Health Services | Tupelo | Mississippi | 38801 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| NYU Winthrop Hospital | Mineola | New York | 11501 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Weill Cornell Medical Center | New York | New York | 10021 | United States |
| Rochester General Hospital | Rochester | New York | 14621 | United States |
| St. Joseph's Hospital Health Center | Syracuse | New York | 13203 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Durham VA Medical Center | Durham | North Carolina | 27705 | United States |
| Moses Cone Memorial Hospital | Greensboro | North Carolina | 27401 | United States |
| North Carolina Heart and Vascular | Raleigh | North Carolina | 27607 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 19103 | United States |
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Robert Packer Hospital | Sayre | Pennsylvania | 18840 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Austin Heart | Round Rock | Texas | 78681 | United States |
| South Texas Cardiology Institute | San Antonio | Texas | 78212 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Swedish Hospital Medical Center | Seattle | Washington | 98122 | United States |
| Shonan Kamakura General Hospital | Kamakura | Japan |
| Kanazawa Cardiovascular Hospital | Kanazawa | Japan |
| Kokura Memorial Hospital | Kitakyushu | Japan |
| Medical Corporation Association Sakura Association Takahashi Hospital | Kobe | Japan |
| Ohara Healthcare Foundation Kurashiki Central Hospital | Kurashiki | Japan |
| Shin Koga Hospital | Kurume | Japan |
| Miyazaki Medical Association | Miyazaki | Japan |
| The Sakakibara Heart Institute of Okayama | Okayama | Japan |
| Sapporo Higashi Tokushukai Hospital | Sapporo | Japan |
| Meander Medisch Centrum | Amersfoort | Netherlands |
| OLVG loc Oost | Amsterdam | Netherlands |
| Tergooi Ziekenhuis | Blaricum | Netherlands |
| Amphia Ziekenhuis | Breda | Netherlands |
| Albert Schweitzer Ziekenhuis | Dordrecht | Netherlands |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| St Antonius Ziekenhuis | Nieuwegein | Netherlands |
| HAGA Ziekenhuis | The Hague | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| Derived |
| Mauri L, Doros G, Rao SV, Cohen DJ, Yakubov S, Lasala J, Wong SC, Zidar J, Kereiakes DJ. The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale. Am Heart J. 2019 Oct;216:82-90. doi: 10.1016/j.ahj.2019.07.003. Epub 2019 Jul 13. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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