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BioFreedom US IDE Feasibility Trial

NCT02131142 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2015-04-01

No results posted yet for this study

Summary

The purpose of this study is to collect additional safety and effectiveness data for on the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in patients with native, de novo coronary artery disease.

Conditions

  • Ischemic Heart Disease
  • Stable Angina
  • Unstable Angina
  • Silent Ischemia

Interventions

DEVICE

BioFreedom drug coated coronary stent

Placement of a BioFreedom drug coated stent in a narrow coronary artery

Sponsors & Collaborators

  • Biosensors Europe SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-08-31
Completion
2019-07-31

Countries

  • United States

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 NCT02131142 on ClinicalTrials.gov