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Clinical Trials/NCT01328197
NCT01328197CompletedPhase 1

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

Bolton Medical12 sites in 1 country30 target enrollmentStarted: June 1, 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
30
Locations
12
Primary Endpoint
major morbidity and mortality
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Treovance

Experimental

Intervention: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System (Device)

Outcomes

Primary Outcomes

major morbidity and mortality

Time Frame: 1, 6, 12 months

Secondary Outcomes

  • Device performance(implant, 1, 6, and 12 months)

Investigators

Sponsor
Bolton Medical
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (12)

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Treovance Stent-Graft With Navitel... | Clinical Trial