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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bolton Medical Identifier:
First received: March 31, 2011
Last updated: February 11, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Abdominal Aortic Aneurysms
Device: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bolton Medical:

Primary Outcome Measures:
  • major morbidity and mortality [ Time Frame: 1, 6, 12 months ]

Secondary Outcome Measures:
  • Device performance [ Time Frame: implant, 1, 6, and 12 months ]
    Rateof delivery/deployment success will be recorded. Rates of endoleak, patency, migration will be documented a 1, 6, 12 months

Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: January 2017
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treovance Device: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
Stent-graft implant


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01328197

United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
Spectrum Health System
Grand Rapids, Michigan, United States, 49503
United States, North Carolina
Carolinas Sanger Heart and Vascular
Charlotte, North Carolina, United States, 28203
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Sentara Heart Hospital
Norfolk, Virginia, United States, 22042
Sponsors and Collaborators
Bolton Medical
  More Information

Responsible Party: Bolton Medical Identifier: NCT01328197     History of Changes
Other Study ID Numbers: IP-0006-10
Study First Received: March 31, 2011
Last Updated: February 11, 2016

Keywords provided by Bolton Medical:

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on May 25, 2017