Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

Abdominal Aortic Aneurysms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328197
• Other study ID #: IP-0006-10
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2011
• Last updated: December 18, 2017
• Start date: June 2011
• Est. completion date: June 2017

Study information

• Verified date: December 2017
• Source: Bolton Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2017
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
Stent-graft implant

Locations

Country	Name	City	State
United States	Carolinas Sanger Heart and Vascular	Charlotte	North Carolina
United States	Spectrum Health System	Grand Rapids	Michigan
United States	East Carolina University	Greenville	North Carolina
United States	Sentara Heart Hospital	Norfolk	Virginia
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bolton Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major morbidity and mortality		1, 6, 12 months
Secondary	Device performance	Rateof delivery/deployment success will be recorded. Rates of endoleak, patency, migration will be documented a 1, 6, 12 months	implant, 1, 6, and 12 months