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A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection

NCT00742274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2013-12-04

Study results available
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Summary

The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B aortic dissections.

Conditions

  • Aortic Diseases

Interventions

DEVICE

Gore TAG Endoprosthesis

Implant Gore TAG device with Best Medical therapy per physician discretion

OTHER

Best Medical Therapy

Best Medical therapy is regimen of antihypertensive medications used to maintain blood pressure below 125/80 mm/Hg throughout the entire follow-up period. Because BMT is assessed by blood pressure response to medication, specific medication regimens for each patient will differ. The typical regimen consists of 1 to 4 concomitant antihypertensive medications that may include angiotensin converting enzyme (ACE) inhibitors, alpha blockers, beta blockers, calcium channel blockers, diuretics, and/or vasodilators.

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Jan Brunkwall, MD, PhD · Kilinkum der Universitat zu Koln

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-02-29
Completion
2013-10-31

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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 NCT00742274 on ClinicalTrials.gov