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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bolton Medical
ClinicalTrials.gov Identifier:
NCT01328197
First received: March 31, 2011
Last updated: May 30, 2014
Last verified: May 2014

March 31, 2011
May 30, 2014
June 2011
April 2013   (final data collection date for primary outcome measure)
major morbidity and mortality [ Time Frame: 1, 6, 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01328197 on ClinicalTrials.gov Archive Site
Device performance [ Time Frame: implant, 1, 6, and 12 months ] [ Designated as safety issue: Yes ]
Rateof delivery/deployment success will be recorded. Rates of endoleak, patency, migration will be documented a 1, 6, 12 months
Device performance [ Time Frame: implant, 1, 6, and 12 months ] [ Designated as safety issue: Yes ]
Assessment of delivery/deployment, endoleak, patency, migration
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Abdominal Aortic Aneurysms
Device: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
Stent-graft implant
Experimental: Treovance
Intervention: Device: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
January 2017
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01328197
IP-0006-10
Yes
Bolton Medical
Bolton Medical
Not Provided
Not Provided
Bolton Medical
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP