A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent System
NCT ID: NCT04807439
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2021-04-14
2023-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Robert C Stoler, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor Heart and Vascular Hospital
Locations
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Yale University
New Haven, Connecticut, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Wake Medical Center
Raleigh, North Carolina, United States
Oregon Health Sciences University
Portland, Oregon, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
Inova Fairfax Hospital
Fairfax, Virginia, United States
Countries
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Other Identifiers
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92226704
Identifier Type: -
Identifier Source: org_study_id
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