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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01328197
Recruitment Status : Active, not recruiting
First Posted : April 4, 2011
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2011
Primary Completion Date : April 2013
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Treovance Device: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
Stent-graft implant


Outcome Measures

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

Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT01328197     History of Changes
Other Study ID Numbers: IP-0006-10
First Posted: April 4, 2011    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016

Keywords provided by Bolton Medical:
Treovance
aneurysm
AAA

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