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Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter

NCT01635881 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-11-06

Study results available
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Summary

To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary arteries or bypass grafts.

Conditions

Interventions

DEVICE

Emerge™ 1.20 mm PTCA Dilatation Catheter

The Emerge 1.20 mm device is the next-generation Boston Scientific PTCA dilatation catheter. It is a sterile, single-use, intravascular medical device used to improve lumen diameter. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • David E Kandzari, MD · Director, Interventional Cardiology, Chief Scientific Officer, Piedmont Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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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 NCT01635881 on ClinicalTrials.gov