A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent System
A U.S. Post-Approval Study of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System Evaluating the SYNERGY XLV (MEGATRON) Stent System
1 other identifier
observational
100
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2021
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2021
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedStudy Start
First participant enrolled
April 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2023
CompletedOctober 23, 2023
October 1, 2023
1.3 years
March 16, 2021
October 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Clinical endpoints
At Hospital Discharge (typically 1-2 days post index procedure), and at 6 months, 12 months, 2 years
Periprocedural endpoints
At Hospital Discharge (typically 1-2 days post index procedure)
Study Arms (1)
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).
Interventions
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.
Eligibility Criteria
Eligible patients include those with atherosclerotic coronary lesions with vessel diameters that can appropriately be treated with a SYNERGY Megatron stent according to the commercially approved SYNERGY IFU and the site's local standard of care.
You may qualify if:
- Patient requires treatment with a SYNERGY XLV (Megatron) stent
You may not qualify if:
- Planned treatment with a non-SYNERGY stent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Yale University
New Haven, Connecticut, 06520, United States
Clearwater Cardiovascular Consultants
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
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226, United States
Inova Fairfax Hospital
Fairfax, Virginia, 22042, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert C Stoler, MD
Baylor Heart and Vascular Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2021
First Posted
March 19, 2021
Study Start
April 14, 2021
Primary Completion
August 19, 2022
Study Completion
August 18, 2023
Last Updated
October 23, 2023
Record last verified: 2023-10