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Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents

NCT02464397 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2015-06-08

No results posted yet for this study

Summary

The purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS) and SYNERGY™ everolimus-eluting stent (EES) in patients with acute coronary syndromes requiring percutaneous coronary intervention.

Patients treated with BAS will be treated with DAPT for at least 4 weeks after the procedure followed by aspirin alone, while patients in the EES group will be treated with DAPT, at least for 6 months post procedure. In addition, this study will collect initial information about the safety and effectiveness of the BAS in comparison with EES group at 30 days, 6 months, and 12 months.

Conditions

  • Acute Coronary Syndrome

Interventions

DEVICE

Stent

In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion

Sponsors & Collaborators

  • The Hospital District of Satakunta

    lead OTHER

Principal Investigators

  • Pasi P Karjalainen, MD, phd · Heart Center, Satakunta Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-08-31
Completion
2017-08-31

Countries

  • Belgium
  • Finland

Study Locations

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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 NCT02464397 on ClinicalTrials.gov