A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent System
Study Details
Study Description
Brief Summary
This is a post-market, standard of care, real-world observational study to assess the clinical outcomes of the SYNERGY XLV (MEGATRON) Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 28 mm in length (by visual estimate) in native coronary arteries ≥3.50 mm to ≤5.00 mm in diameter (by visual estimate). This Post Approval study is a cohort associated with the Evolve 4.5/5.0 (SYNERGY LV) Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT03875651.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SYNERGY XLV (Megatron) Coronary Stent System 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). |
Device: SYNERGY XLV (Megatron) Coronary Stent System
The SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >3.50 mm to <5.00 mm in diameter in lesions <28 mm in length.
|
Outcome Measures
Primary Outcome Measures
- Target Lesion Failure (TLF) rate [12 Months]
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.
Secondary Outcome Measures
- Clinical endpoints [At Hospital Discharge (typically 1-2 days post index procedure), and at 6 months, 12 months, 2 years]
TLR rate, TLF rate (primary endpoint at 12 months), Target vessel revascularization (TVR) rate, Target vessel failure (TVF) rate, MI (Q-wave and non-Q-wave) rate, Cardiac death rate, Non-cardiac death rate, All death rate, Cardiac death or MI rate, All death or MI rate, All death/MI/TVR rate, Stent thrombosis rates (ARC)
- Periprocedural endpoints [At Hospital Discharge (typically 1-2 days post index procedure)]
Technical success rate, Clinical procedural success rate
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patient requires treatment with a SYNERGY XLV (Megatron) stent
Exclusion Criteria:
- Planned treatment with a non-SYNERGY stent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale University | New Haven | Connecticut | United States | 06520 |
| 2 | Clearwater Cardiovascular Consultants | Clearwater | Florida | United States | 33756 |
| 3 | Beth Israel Deaconness Medical Center | Boston | Massachusetts | United States | 02215 |
| 4 | North Kansas City Hospital | Kansas City | Missouri | United States | 64116 |
| 5 | Wake Medical Center | Raleigh | North Carolina | United States | 27607 |
| 6 | Oregon Health Science University | Portland | Oregon | United States | 97239 |
| 7 | Baylor Heart and Vascular Hospital | Dallas | Texas | United States | 75226 |
| 8 | Inova Fairfax Hospital | Fairfax | Virginia | United States | 22042 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Robert C Stoler, MD, Baylor Heart and Vascular Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 92226704