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Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

Primary Purpose

Thoracic Aortic Aneurysm, Penetrating Ulcers

Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Relay Thoracic Stent-Graft
Sponsored by
Bolton Medical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Thoracic Aortic Aneurysm focused on measuring Relay, Thoracic, Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Subjects with diagnosed descending thoracic aneurysm or penetrating ulcer
  • Subjects whose anatomy can accommodate the Relay device
  • Subjects who consent to participate
  • Subjects who agree to a follow-up schedule

Exclusion Criteria:

  • Subjects with lesions other than thoracic aneurysm and penetrating ulcer
  • Subjects with less than 1 year life expectancy
  • Subjects who are pregnant
  • Subjects with medical conditions that wold complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
  • Subjects participating in another investigational study

Sites / Locations

  • Arizona Heart Hospital
  • Washington Hospital Center
  • University of Florida
  • Baptist Cardiac and Vascular Institute
  • Indiana Heart Hospital
  • Massachusetts General Hospital
  • University of Michigan
  • University of North Carolina
  • East Carolina University
  • Cleveland Clinic Foundation
  • Ohio State University
  • University of Pennsylvania
  • University of Pittsburgh
  • Sentara Heart Hospital
  • University Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 31, 2011
Last Updated
November 16, 2012
Sponsor
Bolton Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01327742
Brief Title
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Official Title
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
Study Type
Expanded Access

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bolton Medical

4. Oversight

5. Study Description

Brief Summary
This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Aortic Aneurysm, Penetrating Ulcers
Keywords
Relay, Thoracic, Aneurysm

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Relay Thoracic Stent-Graft
Intervention Description
Device implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Subjects with diagnosed descending thoracic aneurysm or penetrating ulcer Subjects whose anatomy can accommodate the Relay device Subjects who consent to participate Subjects who agree to a follow-up schedule Exclusion Criteria: Subjects with lesions other than thoracic aneurysm and penetrating ulcer Subjects with less than 1 year life expectancy Subjects who are pregnant Subjects with medical conditions that wold complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease) Subjects participating in another investigational study
Facility Information:
Facility Name
Arizona Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Baptist Cardiac and Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Indiana Heart Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Sentara Heart Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
University Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

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