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BIOHELIX-I Bare Metal Stent Study

NCT01612767 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 329

Last updated 2018-09-28

Study results available
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Summary

The purpose of this study is to demonstrate the safety and efficacy of the investigational BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.

Conditions

  • Coronary Arteries Disease

Interventions

DEVICE

PRO-Kinetic Energy Stent

Coronary artery stent implant

Sponsors & Collaborators

  • Biotronik, Inc.

    lead INDUSTRY

Principal Investigators

  • Saurabh Gupta, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-09-30
Completion
2017-11-30

Countries

  • United States
  • Colombia
  • Germany
  • Latvia
  • Netherlands

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 NCT01612767 on ClinicalTrials.gov