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Shockwave Coronary Lithoplasty Study

NCT02758379 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-07-21

No results posted yet for this study

Summary

The objective of this clinical trial is to study the early safety and feasibility of the Shockwave Coronary Lithoplasty System. To demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, de novo coronary lesions.

Conditions

  • Coronary Stenosis

Interventions

DEVICE

Shockwave Coronary Lithoplasty System

Lithotripsy shockwaves are used to fracture calcified lesions in the coronary arteries

Sponsors & Collaborators

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Pacific Clinical Research Group

    collaborator OTHER

  • Shockwave Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Whitbourn, M.D. · St. Vincent Hospital, Melbourne, Australia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • Australia

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 NCT02758379 on ClinicalTrials.gov