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Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis

NCT00538759 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-10-01

Study results available
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Summary

The objective of the RADAR trial is to determine the impact of External Beam Radiation Therapy (EBRT) on aortic valve restenosis following successful percutaneous balloon aortic valvuloplasty (BAV) in elderly patients with severe calcific aortic stenosis.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

External beam radiation therapy

Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty

OTHER

Sham Control

Sponsors & Collaborators

  • Twin Cities Heart Foundation

    collaborator UNKNOWN

  • Minneapolis Heart Institute

    collaborator OTHER

  • Minneapolis Heart Institute Foundation

    lead OTHER

Principal Investigators

  • Wes R Pedersen, MD · Minneapolis Heart Institute Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

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 NCT00538759 on ClinicalTrials.gov