CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
Relay Thoracic Stent-Graft +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00435942
NCT00435942N/ACompleted
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Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies

Bolton Medical·interventional·Posted Feb 16, 2007·Updated Jan 16, 2018

In Brief

A clinical study evaluating Relay Thoracic Stent-Graft and Open Repair for Thoracic Aortic Aneurysms and and Penetrating Atherosclerotic Ulcers. Completed, enrolled 180 participants across 27 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThoracic Aortic Aneurysms, and Penetrating Atherosclerotic Ulcers
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 16, 2007
Enrollment StartJan 1, 2007
Primary CompletionApr 1, 2011
Study CompletionMay 15, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.4 years ago

Interventions

Relay Thoracic Stent-Graftdevice

implant

Open Repairprocedure

Open surgery