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

Primary Purpose

Thoracic Aortic Aneurysms, and Penetrating Atherosclerotic Ulcers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relay Thoracic Stent-Graft
Open Repair
Sponsored by
Bolton Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Aortic Aneurysms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers
  • Subjects who are at least 18 years of age
  • Subjects whose anatomy can accommodate the Relay device
  • Subjects who consent to participate
  • Subjects who agree to comply with follow-up schedule

Exclusion Criteria:

  • Subjects with non-aneurysm lesions
  • Subjects with less than 1 year life expectancy
  • Subjects who are pregnant
  • Subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.)
  • Subjects participating in another investigational study

Sites / Locations

  • Arizona Heart Hospital
  • University of Arizona
  • University of California-San Francisco
  • Washington Hospital Center
  • University of Florida
  • University of Miami
  • Baptist Cardiac and Vascular Institute
  • Emory University
  • Rockford Memorial Hospital
  • Clarian Cardiovascular
  • Indiana Heart Hospial
  • Massachusetts General Hospital
  • University of Michigan
  • The Mayo Clinic
  • Albany Medical Center
  • New York Presbyterian Hospital --Columbia/Cornell University
  • University of North Carolina at Chapel Hill
  • East Carolina University
  • Cleveland Clinic Foundation
  • Ohio State University
  • Hospital of the University of Pennsylvania/Penn Presbyterian
  • University of Pittsburgh
  • Methodist Hospital
  • INOVA Fairfax Hospital
  • Sentara Heart Hospital
  • University of Washington
  • Aurora St. Luke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Endovascular Treatment arm to be implanted with Relay device

Surgical Control, underwent open repair

Outcomes

Primary Outcome Measures

Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects
The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure. The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.
Primary Safety Endpoint: Distribution of Major Adverse Events
The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure

Secondary Outcome Measures

Full Information

First Posted
February 14, 2007
Last Updated
December 18, 2017
Sponsor
Bolton Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00435942
Brief Title
Phase II 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
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 15, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Aortic Aneurysms, and Penetrating Atherosclerotic Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Endovascular Treatment arm to be implanted with Relay device
Arm Title
2
Arm Type
Active Comparator
Arm Description
Surgical Control, underwent open repair
Intervention Type
Device
Intervention Name(s)
Relay Thoracic Stent-Graft
Intervention Description
implant
Intervention Type
Procedure
Intervention Name(s)
Open Repair
Intervention Description
Open surgery
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects
Description
The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure. The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.
Time Frame
1 year
Title
Primary Safety Endpoint: Distribution of Major Adverse Events
Description
The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers Subjects who are at least 18 years of age Subjects whose anatomy can accommodate the Relay device Subjects who consent to participate Subjects who agree to comply with follow-up schedule Exclusion Criteria: Subjects with non-aneurysm lesions Subjects with less than 1 year life expectancy Subjects who are pregnant Subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.) Subjects participating in another investigational study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Farber, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of California-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2975
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Cardiac and Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rockford Memorial Hospital
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61103
Country
United States
Facility Name
Clarian Cardiovascular
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana Heart Hospial
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
The Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York Presbyterian Hospital --Columbia/Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina at Chapel Hill
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
Hospital of the University of Pennsylvania/Penn Presbyterian
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
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sentara Heart Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Aurora St. Luke's Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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