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COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT

NCT01925794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2021-12-22

Study results available
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Summary

This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year and annually for 5 years post index stenting procedure.

Conditions

Interventions

DEVICE

COBRA PzF

Sponsors & Collaborators

  • CeloNova BioSciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Donald Cutlip, MD · Executive Director, Clinical Investigation, Harvard Clinical Research Institute

  • Sigmund Sliber, MD · Professor of Medicine at The University of Munich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-21
Primary Completion
2015-11-30
Completion
2020-03-02

Countries

  • United States
  • France
  • Germany
  • Latvia
  • Serbia
  • Spain
  • Switzerland

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 NCT01925794 on ClinicalTrials.gov