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

Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies

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 Overview

• Status: Completed
• Conditions: Thoracic Aortic Aneurysms; and Penetrating Atherosclerotic Ulcers
• Intervention / Treatment: Device: Relay Thoracic Stent-Graft; Procedure: Open Repair

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Arizona Heart Hospital
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • California
    • San Francisco, California, United States, 94143
      • University of California-San Francisco
  • District of Columbia
    • Washington, District of Columbia, United States, 20010-2975
      • Washington Hospital Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Miami, Florida, United States, 33176
      • Baptist Cardiac and Vascular Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Rockford, Illinois, United States, 61103
      • Rockford Memorial Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Clarian Cardiovascular
    • Indianapolis, Indiana, United States, 46250
      • Indiana Heart Hospial
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • The Mayo Clinic
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital --Columbia/Cornell University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania/Penn Presbyterian
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Texas
    • Houston, Texas, United States, 77030
      • Methodist Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Norfolk, Virginia, United States, 23510
      • Sentara Heart Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Endovascular Treatment arm to be implanted with Relay device	Device: Relay Thoracic Stent-Graft; implant
ACTIVE_COMPARATOR: 2; Surgical Control, underwent open repair	Procedure: Open Repair; Open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
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	1 year

Collaborators and Investigators

• Sponsor: Bolton Medical

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): May 15, 2017

Study Registration Dates

• First Submitted: February 14, 2007
• First Submitted That Met QC Criteria: February 14, 2007
• First Posted (ESTIMATE): February 16, 2007

Study Record Updates

• Last Update Posted (ACTUAL): January 16, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: IP-0004-06