AtherosclerosisNCT04807439
A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent System
An observational study of Atherosclerosis and Heart Diseases, Coronary, run by Boston Scientific Corporation at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Heart Diseases, Coronary, Coronary Artery Disease
- What is being tested?
- SYNERGY XLV (Megatron) Coronary Stent System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 8 sitesUnited States
- Study dates
- 14 Apr 2021to 18 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient requires treatment with a SYNERGY XLV (Megatron) stent
Who cannot join
- Planned treatment with a non-SYNERGY stent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Beth Israel Deaconness Medical Center
Boston, Massachusetts, 02215
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226
Inova Fairfax Hospital
Fairfax, Virginia, 22042
North Kansas City Hospital
Kansas City, Missouri, 64116
Yale University
New Haven, Connecticut, 06520
Oregon Health Sciences University
Portland, Oregon, 97239
Wake Medical Center
Raleigh, North Carolina, 27607
About this study
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
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.
- Conditions
- Atherosclerosis, Heart Diseases, Coronary, Coronary Artery Disease, Cardiovascular Diseases
- Being tested
- SYNERGY XLV (Megatron) Coronary Stent System
- Keywords
- Drug-Eluting Stents
- Medical subject headings
- Atherosclerosis, Coronary Disease, Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNERGY XLV (Megatron) Coronary Stent SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: SYNERGY XLV (Megatron) Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (2)
Clinical endpoints
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)
Measured: At Hospital Discharge (typically 1-2 days post index procedure), and at 6 months, 12 months, 2 years
Periprocedural endpoints
Technical success rate, Clinical procedural success rate
Measured: At Hospital Discharge (typically 1-2 days post index procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start14 Apr 2021
- Primary completion19 Aug 2022
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert C Stoler, MD, Principal investigator, Baylor Heart and Vascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807439
- Sponsor's protocol ID
- 92226704
- Status last verified
- Oct 2023
- First submitted
- 16 Mar 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: 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).
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04807439
- Acronym / sponsor ID
- 92226704
- Conditions
- Atherosclerosis, Heart Diseases, Coronary, Coronary Artery Disease, Cardiovascular Diseases
- Keywords
- Drug-Eluting Stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYNERGY XLV (Megatron) Coronary Stent System | – | Device: SYNERGY XLV (Megatron) Coronary Stent SystemThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patient requires treatment with a SYNERGY XLV (Megatron) stent
Key exclusion criteria (1 listed)
- Planned treatment with a non-SYNERGY stent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYNERGY XLV (Megatron) Coronary Stent SystemThe 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. | Device | SYNERGY XLV (Megatron) Coronary Stent System |
Primary outcome
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.
2 secondary outcomes
Clinical endpoints
Time frame: At Hospital Discharge (typically 1-2 days post index procedure), and at 6 months, 12 months, 2 years
Periprocedural endpoints
Time frame: At Hospital Discharge (typically 1-2 days post index procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C Stoler, MD principal investigator
Baylor Heart and Vascular Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Heart Diseases, Coronary, run by Boston Scientific Corporation at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) rate (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.