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Valvuloplasty Scoring Balloon Catheter First-in-Man Study

NCT01514994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-04-18

No results posted yet for this study

Summary

The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of critical aortic valve stenosis.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

AngioScore's Valvuloplasty Scoring Balloon

All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.

Sponsors & Collaborators

  • Spectranetics Corporation

    lead INDUSTRY

Principal Investigators

  • John G. Webb, MD · St. Paul's Hospital, Vancouver, Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-12-31
Completion
2015-09-30

Countries

  • Canada

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 NCT01514994 on ClinicalTrials.gov