SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance and Dual Ant… (NCT03606642) | Clinical Trial Compass
TerminatedPhase 2
SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance and Dual Anti-Platelet Therapy
Stopped: The DSMC March 16, 2022 reviewed of Interim Analysis and recommendation due to no glaring outcomes found to date.
United States50 participantsStarted 2018-11-19
Plain-language summary
The purpose of this study is to see if one month of dual antiplatelet therapy (DAPT) combined with the placement of the Synergy® Stent with IVUS (intravascular ultrasound) is safe for patients who are at high risk of bleeding (HBR).
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject must have had implantation of at least one Synergy Stent and the use of Boston Scientific IVUS for guided stent implantation
. All implanted stents must be post dilated and must meet the following IVUS success criteria:
. Stent procedure performed by an approved investigator
. Vessel diameter ≥ 2.25 mm and ≤4.0 mm and lesion length ≤34mm
. Pre-dilatation is up to the discretion of the investigator
Exclusion criteria
. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
. Subject with treatment with another coronary stent, other than SYNERGY Stent during the index procedure
. Subject with a planned staged procedure \>7 days following the index procedure. (Note: Planned staged procedures are allowed if performed within 7 days of the index procedure and only when SYNERGY stents are used for both the index and staged procedure). Discontinuation of DAPT should occur 1 month after the last PCI procedure is completed.
. A staged procedure cannot in a 3rd epicardial vessel if 2 epicardial vessels were treated during the index procedure
. Subject has a known allergy to: contrast (that cannot be adequately pre-medicated), the SYNERGY Stent system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)
. Subject previously treated at any time with intravascular brachytherapy
. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding