- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02907762
Aorfix Intelliflex First in Human Study (FIH-NZ)
Aorfix™ Generation IV Delivery System "IntelliFlex™" Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
- Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.
Description
Inclusion Criteria:
- Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
- Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.
Exclusion Criteria:
- Do not comply with the indications for Aorfix™ in the IFU.
- Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care of the investigative site.
- Unwillingness or inability to provide informed consent to both the study and the EVAR procedure.
- Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with Successful Implant Delivery (30d)
Time Frame: 1 Month
|
Successful implant delivery is also called Primary Technical Success, defined as successful introduction and deployment of the device in the absence of surgical conversion or mortality, Type I or III endoleaks, or graft limb obstruction. The numbers of participants having Primary Technical Success on completion of the index procedure and Clinical Success 12 months after the procedure will be recorded. |
1 Month
|
Number of participants with Treatment Success (1year)
Time Frame: 12 Months
|
Treatment success, or Clinical Success, requires successful deployment of the endovascular device at the intended location without death as a result of aneurysm-related treatment, Type I or III endoleak, graft infection or thrombosis, aneurysm expansion (diameter >=5 mm, or volume >=5%), aneurysm rupture, or conversion to open repair. The numbers of participants having Primary Technical Success on completion of the index procedure and Clinical Success 12 months after the procedure will be recorded. |
12 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Holden, MD, University of Auckland, NZ
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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