Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Heart Diseases, Coronary
Conditions
Keywords
Drug-Eluting Stents
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.
Interventions
DEVICESYNERGY 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.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient requires treatment with a SYNERGY XLV (Megatron) stent
Exclusion criteria
* Planned treatment with a non-SYNERGY stent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed