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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.
Sponsor:
Information provided by (Responsible Party):
Bolton Medical
ClinicalTrials.gov Identifier:
NCT01328197
First received: March 31, 2011
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Bolton Medical:

Primary Outcome Measures:
  • major morbidity and mortality [ Time Frame: 1, 6, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: January 2017
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328197

Locations
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

No publications provided

Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT01328197     History of Changes
Other Study ID Numbers: IP-0006-10
Study First Received: March 31, 2011
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bolton Medical:
Treovance
aneurysm
AAA

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on June 18, 2013