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EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries > 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYNERGY 4.50 mm and 5.0 mm Coronary Stent System | Device | The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System), manufactured by BSC, is a device/drug combination product comprised of two regulated components: a device (Coronary Stent System) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating). |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) rate | 12-month Target Lesion Failure (TLF) rate, defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death. | 12-months |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible patients include those with atherosclerotic coronary lesions with vessel diameters that can appropriately be treated with 4.50 mm and/or 5.00 mm stents according to the commercially approved SYNERGY DFU
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| Name | Affiliation | Role |
|---|---|---|
| Robert C Stoler, MD | Baylor Heart and Vascular Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States | ||
| Clearwater Cardiovascular Consultants |
The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy: (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
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| Clearwater |
| Florida |
| 33756 |
| United States |
| Beth Israel Deaconness Medical Center | Boston | Massachusetts | 02215 | United States |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | United States |
| Wake Medical Center | Raleigh | North Carolina | 27607 | United States |
| Lindner Center for Research and Education at Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Oregon Health Science University | Portland | Oregon | 97239 | United States |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | United States |
| Inova Fairfax Hospital | Fairfax | Virginia | 22042 | United States |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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