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Xience Versus Synergy in Left Main PCI

NCT02303717 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 818

Last updated 2014-12-01

No results posted yet for this study

Summary

A prospective, randomized, multicenter study in patients with an indication for coronary artery revascularisation who have been accepted for percutaneous coronary intervention (PCI) of the left main coronary artery. Patients will undergo standard PCI of the left main coronary artery and will be randomized in a 1:1 fashion to the Synergy stent or to the XIENCE stent. Dual antiplatelet therapy (DAPT) will be stopped at t=4 months in the Synergy arm whereas in the control arm DAPT will be continued for 12 months. A subgroup of 100 patients will have control angiography with Optical Coherence Tomography (OCT) at t=3 months after treatment.

Conditions

Interventions

DEVICE

Percutaneous coronary intervention

Percutaneous coronary stent implantation

DRUG

Dual antiplatelet therapy

Dual antiplatelet therapy with aspirin and either clopidogrel, prasugrel or ticagrelor will be recommended for 12 months duration in the Xience stent arm but only 4 months duration in the Synergy stent arm.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Venn Life Sciences

    collaborator OTHER

  • Cardialysis B.V.

    collaborator INDUSTRY

  • Diagram B.V.

    collaborator OTHER

  • NHS National Waiting Times Centre Board

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-12-31
Completion
2020-12-31

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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 NCT02303717 on ClinicalTrials.gov