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A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04807439
Recruitment Status : Active, not recruiting
First Posted : March 19, 2021
Last Update Posted : February 22, 2022
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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
Atherosclerosis Heart Diseases, Coronary Coronary Artery Disease Cardiovascular Diseases Device: SYNERGY XLV (Megatron) Coronary Stent System

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A U.S. Post-Approval Study of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System Evaluating the SYNERGY XLV (MEGATRON) Stent System
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : August 9, 2022
Estimated Study Completion Date : August 9, 2023
Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Target Lesion Failure (TLF) rate [ Time Frame: 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 :
  1. Clinical endpoints [ Time Frame: 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)

  2. Periprocedural endpoints [ Time Frame: At Hospital Discharge (typically 1-2 days post index procedure) ]
    Technical success rate, Clinical procedural success rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Patient requires treatment with a SYNERGY XLV (Megatron) stent

Exclusion Criteria:

  • Planned treatment with a non-SYNERGY stent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807439


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States, 33756
United States, Massachusetts
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215
United States, Missouri
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
United States, North Carolina
Wake Medical Center
Raleigh, North Carolina, United States, 27607
United States, Ohio
Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Oregon
Oregon Health Science University
Portland, Oregon, United States, 97239
United States, Texas
Baylor Heart and Vascular Hospital
Dallas, Texas, United States, 75226
United States, Virginia
Inova Fairfax Hospital
Fairfax, Virginia, United States, 22042
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Robert C Stoler, MD Baylor Heart and Vascular Hospital
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04807439    
Other Study ID Numbers: 92226704
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: February 22, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Boston Scientific Corporation:
Drug-Eluting Stents
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Heart Diseases
Atherosclerosis
 Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases