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Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease

NCT00744107 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2009-08-06

No results posted yet for this study

Summary

To demonstrate the safety and efficacy of the Cobra Cobalt Super Alloy Balloon-Expandable Coronary Stent System for the treatment of de novo and restenotic (previously unstented) lesions in native coronary arteries in subjects with coronary artery disease (CAD) having a reference vessel diameter (RVD) between 2.5 - 4.0 mm and a lesion length ≤ 26 mm amenable to percutaneous coronary intervention (PCI) with a single stent in subjects with symptomatic ischemic heart disease.

Conditions

Interventions

DEVICE

PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System

stent placement, single-arm study

Sponsors & Collaborators

  • Baim Institute for Clinical Research

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • Medlogics Device Corporation

    lead INDUSTRY

Principal Investigators

  • Prof. Nicolaus J Reifart, PhD, MD · Main Taunus Kliniken, Kardiologisches

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-07-31
Completion
2010-09-30

Countries

  • Germany
  • Israel
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00744107 on ClinicalTrials.gov