Back to resultsTreovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
Primary Purpose
Abdominal Aortic Aneurysms
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Aortic Aneurysms focused on measuring Treovance, aneurysm, AAA
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Massachusetts
- Spectrum Health System
- Carolinas Sanger Heart and Vascular
- East Carolina University
- University of Pennsylvania
- Sentara Heart Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treovance
Arm Description
Outcomes
Primary Outcome Measures
major morbidity and mortality
Secondary Outcome Measures
Device performance
Rateof delivery/deployment success will be recorded. Rates of endoleak, patency, migration will be documented a 1, 6, 12 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01328197
Brief Title
Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bolton Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms
Keywords
Treovance, aneurysm, AAA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
AAA device
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treovance
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
Intervention Description
Stent-graft implant
Primary Outcome Measure Information:
Title
major morbidity and mortality
Time Frame
1, 6, 12 months
Secondary Outcome Measure Information:
Title
Device performance
Description
Rateof delivery/deployment success will be recorded. Rates of endoleak, patency, migration will be documented a 1, 6, 12 months
Time Frame
implant, 1, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Spectrum Health System
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Carolinas Sanger Heart and Vascular
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sentara Heart Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
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