Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
A Phase I Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
1 other identifier
interventional
30
1 country
6
Brief Summary
The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of this study will permit the establishment of endpoints and clinical design for a subsequent U.S. trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2011
Longer than P75 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2011
CompletedFirst Posted
Study publicly available on registry
April 4, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedDecember 20, 2017
December 1, 2017
1.8 years
March 31, 2011
December 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
major morbidity and mortality
1, 6, 12 months
Secondary Outcomes (1)
Device performance
implant, 1, 6, and 12 months
Study Arms (1)
Treovance
EXPERIMENTALInterventions
Stent-graft implant
Eligibility Criteria
You may qualify if:
- Subjects with diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement
- Subjects with an infrarenal AAA that is \>/= 4.5 cm in diameter for males, or \>/= 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months
- Subjects who consent to participate
- Subjects who agree to comply with the follow-up schedule
You may not qualify if:
- Subjects with dissections, ruptured aneurysms, or symptomatic aneurysms
- Subjects with prior AAA repair
- Subjects with medical conditions that would complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
- Subjects who are pregnant or lactating
- Subjects participating in other investigational studies
- Subjects with less than 2 years life expectancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bolton Medicallead
Study Sites (6)
University of Massachusetts
Worcester, Massachusetts, 01655, United States
Spectrum Health System
Grand Rapids, Michigan, 49503, United States
Carolinas Sanger Heart and Vascular
Charlotte, North Carolina, 28203, United States
East Carolina University
Greenville, North Carolina, 27834, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Sentara Heart Hospital
Norfolk, Virginia, 22042, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2011
First Posted
April 4, 2011
Study Start
June 1, 2011
Primary Completion
April 1, 2013
Study Completion
June 1, 2017
Last Updated
December 20, 2017
Record last verified: 2017-12