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

Sponsored by:	Bolton Medical
Information provided by:	Bolton Medical
ClinicalTrials.gov Identifier:	NCT00435942

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	Device: Relay Thoracic Stent-Graft	Phase II

MedlinePlus related topics: Aneurysms

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies

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:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Endovascular Treatment arm	Device: Relay Thoracic Stent-Graft implant
2: Active Comparator 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
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

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

Contacts

Contact: Cynthia O Weaver

954-536-3588

cweaver@boltonmedical.com

Show 25 Study Locations

Sponsors and Collaborators

Bolton Medical

Investigators

Principal Investigator:

Mark Farber, MD

University of North Carolina

More Information

Responsible Party:	Bolton Medical, Inc. ( Julie Byerly, Director of Regulatory Affairs )
Study ID Numbers:	IP-0004-06
Study First Received:	February 14, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00435942
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Aortic Diseases
Aortic Aneurysm, Thoracic
Aneurysm
Vascular Diseases
Aortic Aneurysm

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009