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SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance and Dual Anti-Platelet Therapy

NCT03606642 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-27

Study results available
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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).

Conditions

Interventions

DRUG

Dual Antiplatelet (DAPT) Therapy

DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin. Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg. P2Y12 Inhibitor Loading Dose (investigator preference): Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1. P2Y12 Inhibitor Maintenance Dose (investigator preference): Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.

DEVICE

The Synergy® stent

IVUS guided stent

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • HonorHealth Research Institute

    lead OTHER

Principal Investigators

  • David Rizik, MD · HonorHealth Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2021-12-31
Completion
2022-08-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03606642 on ClinicalTrials.gov