Aorfix Intelliflex First in Human Study

Aortic Aneurysm, Abdominal Clinical Trial

— FIH-NZ  

Official title:

Aorfix™ Generation IV Delivery System "IntelliFlex™" Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02907762
• Other study ID #: 2015-07
• Status: Active, not recruiting
• Start date: November 2015
• Est. completion date: November 2021

Study information

• Verified date: October 2021
• Source: Lombard Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair.

2. Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.

Exclusion Criteria:

1. Do not comply with the indications for Aorfix™ in the IFU.

2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care of the investigative site.

3. Unwillingness or inability to provide informed consent to both the study and the EVAR procedure.

4. 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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Endovascular aneurysm repair EVAR

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lombard Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Successful Implant Delivery (30d)	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
Primary	Number of participants with Treatment Success (1year)	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