To assess the safety and performance of Aorfix* Stent Graft in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac arteries.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are acute technical success, initial performance and
safety at 1-month follow up. Technical success is defined as successful passage
of delivery system to the landing zone accurate placement of the device at the
target zone, accurate positioning of the contra-lateral limb and withdrawal of
the delivery system post deployment. Performance is defined as aneurysmal
exclusion and flow restoration as evidenced by freedom from acute endoleak.
Safety is defined as the absence of clinical complications during and after the
clinical procedure (up top 1-month post-procedure).
Secondary outcome
Secondary endpoints will examine recovery factors: operative time, ICU
duration, blood loss, days to normal diet, days to discharge, days to
ambulation, freedom from non-clinical events, need for secondary procedure and
conversion to uni-iliac. Also safety at 6-month follow-up as measured by
serious adverse events that occur up to 6-months post-procedure.
Background summary
ARBITER-II: Aorfix* Bifurcated Safety and Performance Trial: Phase II,
Angulated Vessels.
The most common treatment for AAAs is invasive open abdominal surgery. Early in
the last decade a less invasive technique (endovascular stent grafting) was
developed, beneficial to non-surgical AAA candidates. The Aorfix* has been
designed by surgeons and engineers with the treatment of challenging cases in
mind. Owing to this device*s unique design, it is hoped that the device will
help to overcome some of the potential complications that exist with current
endovascular stent grafts, such as device malpositioning, device migration or
incomplete device deployment.
Study objective
To assess the safety and performance of Aorfix* Stent Graft in the treatment of
Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel
angulation exists at the neck of the aneurysm or in the common iliac arteries.
Study design
The investigation is a prospective open label, single arm, multi-centre
clinical study designed to assess the safety and performance of the Aorfix*
stent graft.
Intervention
Endovascular repair of an abdominal aortic aneurysm is an minimally
interventional procedure that will allow aneurysm exclusion using a stent graft
passed inside the aorta either percutaneously or from a small groin incision.
Study burden and risks
The potential adverse effects, risks or hazards for research participants are
expected to be similar to those associated to treatment with other stent
grafts. Endovascular grafting is a less invasive procedure than open surgery,
involving less cutting and may result in smaller scars. This procedure may
enable the patient to leave the hospital sooner and recover more quickly, with
less pain and possibly reduced short term risks of complications and death than
traditional surgery. Additionally, the use of Aorfix* may enable fewer
complications associated with other endovascular stent grafts, such as device
malposition, migration or incomplete device deployment to enable a more
successful procedure. Successful treatment of the aneurysm with Aorfix* may
also result in a high likelihood of the patient returning to normal life.
Recently an important trial has suggested that in certain specific cases of
treating AAA, endovascular intervention is superior to traditional surgery.
Lombard Medical House; 4 Trident Park; Didcot
OX11 7HJ
UK
Lombard Medical House; 4 Trident Park; Didcot
OX11 7HJ
UK
Listed location countries
Age
Inclusion criteria
1. Diagnosis of abdominal aortic aneurysm 50 mm or larger in diameter, 40 mm or larger in diameter if symptomatic (i.e. pain, embolisation), or documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery(ies), or any saccular aneurysm.
2. Infrarenal neck with a minimum length of 15 mm and a neck angulation between 60° and 90°, as assessed in 3 dimensions.
3. The iliac artery diameter must be of appropriate diameter (1 mm smaller than the device diameter), with an appropriate distal landing length. The tortuosity of the common or external iliac arteries or femoral arteries must be low to medium (refer to operations manual).
4. Patient provides written informed consent.
5. Patients >18 years who are suitable for endovascular repair.
6. Patient fit for endovascular surgery, with a diameter at the access sites of 7mm or larger bilaterally.
7. Patient has a life expectancy longer than the duration of the study.
Exclusion criteria
1. Patient has a ruptured aneurysm.
2. Patient has insufficient length of proximal aneurysm neck (<15mm from aneurysm to lowest renal artery and <20 mm from the aneurysm to the SMA).
3. Aneurysm extends above renal arteries.
4. Proximal neck of aneurysm has significant loose thrombus associated with it, or significant circumferential calcifications.
5. Pregnant or nursing patients.
6. Patient unfit for bail-out surgery and appropriate anaesthesia.
7. Patient with an acute or chronic aortic dissection or mycotic aneurysm (defined by localised asymmetric aneurysm sac).
8. Patient has current non-localised infection.
9. Patient has known allergy to graft materials, Nitinol, or contrast media.
10. Patient*s where imaging is problematic; an example is an obese patient.
11. Patient has co-morbidities that deny vascular access, including small / tortuous access vessels.
12. Patient has highly calcified and tortuous proximal necks or distal landing zones or iliac arteries.
13. Patient has renal failure (serum creatinine >2mg/dL or >176 mmol/l).
14. Patient has connective tissue disease (e.g. Marfan syndrome, Ehlers-Danlos syndrome).
15. Patient has a bleeding diathesis or dyscrasia.
16. Patient is not willing to comply with the follow up sequence, or his geographic location does not allow appropriate follow up.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15252.028.06 |