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Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy

NCT02594501 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 996

Last updated 2020-10-26

No results posted yet for this study

Summary

The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.

Conditions

  • Angina, Stable
  • Angina, Unstable
  • Anticoagulants

Interventions

DEVICE

COBRA PzF

DEVICE

Drug Eluting Stent

Sponsors & Collaborators

  • CeloNova BioSciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Adnan Kastrati · ISAResearch Center Deutsches Herzzentrum München

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-05
Primary Completion
2021-05-31
Completion
2021-11-30
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Germany
  • Italy
  • Latvia
  • Switzerland

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 NCT02594501 on ClinicalTrials.gov