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 range75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Subject must have had implantation of at least one Synergy Stent and the use of Boston Scientific IVUS for guided stent implantation
âś“. All implanted stents must be post dilated and must meet the following IVUS success criteria:
âś“. Stent procedure performed by an approved investigator
✓. Vessel diameter ≥ 2.25 mm and ≤4.0 mm and lesion length ≤34mm
âś“. Pre-dilatation is up to the discretion of the investigator
Exclusion criteria
âś•. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
âś•. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
âś•. Subject with treatment with another coronary stent, other than SYNERGY Stent during the index procedure
âś•. 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.
âś•. A staged procedure cannot in a 3rd epicardial vessel if 2 epicardial vessels were treated during the index procedure
âś•. 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)