NCT00435942 - Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft | Syfrah

Trials Sponsors Conditions Drugs Pricing

Conditions

and Penetrating Atherosclerotic Ulcers Thoracic Aortic Aneurysms

Outcome Measures

Primary Outcomes (2)

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

Study Arms (2)

1

EXPERIMENTAL

Endovascular Treatment arm to be implanted with Relay device

Device: Relay Thoracic Stent-Graft

2

ACTIVE COMPARATOR

Surgical Control, underwent open repair

Procedure: Open Repair

Interventions

Relay Thoracic Stent-GraftDevice

implant

1

Open RepairProcedure

Open surgery

2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers
Subjects who are at least 18 years of age

Sponsors & Collaborators

Bolton Medical
Industrylead

Study Sites (27)

Arizona Heart Hospital

Phoenix, Arizona, 85006, United States

University of Arizona

Tucson, Arizona, 85724, United States

University of California-San Francisco

San Francisco, California, 94143, United States

Washington Hospital Center

Washington D.C., District of Columbia, 20010-2975, United States

University of Florida

Gainesville, Florida, 32610, United States

University of Miami

Miami, Florida, 33136, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicPenetrating Atherosclerotic Ulcer

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesAcute Aortic SyndromeArteriosclerosisArterial Occlusive Diseases

Limitations and Caveats

Many subjects experienced more than one type of event.

Results Point of Contact

Title: Annie Weiller
Organization: Bolton Medical, Inc.

Study Officials

Mark Farber, MD
University of North Carolina
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

180 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR
Expanded Access: Yes

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 16, 2007

Study Start

January 2007

Date type not reported

This date has not been verified as actual or estimated.