Clinical Trials Directory

Trials / Completed

CompletedNCT01612767

BIOHELIX-I Bare Metal Stent Study

The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
329 (actual)
Sponsor
Biotronik, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEPRO-Kinetic Energy StentCoronary artery stent implant

Timeline

Start date
2012-11-01
Primary completion
2015-09-01
Completion
2017-11-01
First posted
2012-06-06
Last updated
2018-09-28
Results posted
2017-05-30

Locations

35 sites across 5 countries: United States, Colombia, Germany, Latvia, Netherlands

Source: ClinicalTrials.gov record NCT01612767. Inclusion in this directory is not an endorsement.

BIOHELIX-I Bare Metal Stent Study (NCT01612767) · Clinical Trials Directory