Aorfix Intelliflex First in Human Study

NCT02907762 | Unknown DMC

• 1 other identifier: 2015-07
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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°.

Conditions

Aortic Aneurysm, Abdominal

Keywords

Endovascular; EVAR; Neck Angulation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

Endovascular aneurysm repair EVAR DEVICE

Also known as: Aorfix Intelliflex

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair. 2. Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.

You may qualify if:

• Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
• Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lombard Medical: lead

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Andrew Holden, MD

  University of Auckland, NZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 20, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10