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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bolton Medical
ClinicalTrials.gov Identifier:
NCT00435942
First received: February 14, 2007
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Thoracic Aortic Aneurysms
and Penetrating Atherosclerotic Ulcers
Device: Relay Thoracic Stent-Graft
Phase 2

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies

Resource links provided by NLM:


Further study details as provided by Bolton Medical:

Primary Outcome Measures:
  • Major device-related adverse events and major morbidity & mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical utility, lesion size increases, vascular complications [ Time Frame: 1, 6, 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2007
Estimated Study Completion Date: May 2015
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Endovascular Treatment arm
Device: Relay Thoracic Stent-Graft
implant
Active Comparator: 2
Surgical Control
Device: Relay Thoracic Stent-Graft
implant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435942

  Show 27 Study Locations
Sponsors and Collaborators
Bolton Medical
Investigators
Principal Investigator: Mark Farber, MD University of North Carolina
  More Information

No publications provided

Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT00435942     History of Changes
Obsolete Identifiers: NCT00998491
Other Study ID Numbers: IP-0004-06
Study First Received: February 14, 2007
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 10, 2014