AAA - Shape Pivotal Trial
Research type
Research Study
Full title
AAA-Shape Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
IRAS ID
337036
Contact name
Ian Loftus
Contact email
Sponsor organisation
Shape Memory Medical Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
Aortic aneurysms represent a disease of the major artery of the body in the abdomen, where the wall of the aorta weakens and dilates over time. In the UK there is a national screening to identify and treat aortic aneurysms early, before they reach a size that put them at risk of bursting (which is usually fatal).
Surgery for aortic aneurysms is often performed using stents to reline the aorta, a procedure called endovascular aneurysm repair or EVAR. This is a lot less invasive and risky than open surgery, where the diseased aorta is replaced with a plastic tube.
However, in some patient stents to not prevent aneurysms continuing to expand, putting patients at increased risk of reintervention, rupture and premature death.
Filling the aneurysm around the stent with something that encourages the space to clot, may prevent this aneurysm expansion.
AAA Shape is multicenter, randomised, open-label trial. It is being performed to determine the safety and effectiveness of IMPEDE-FX RapidFill, a device that will be used to aid shrinkage of the abdominal aortic aneurysm (AAA) sac when used as an adjunct to EVAR in patients undergoing elective surgery. The main outcome will be aneurysm shrinkage ('sac regression').
A total of 180 patients will be enrolled into the study, out of which 120 will be allocated to the treatment arm and 60 to the control arm. Participants will be randomly assigned to either arm. The treatment arm will have both an EVAR device and IMPEDE-FX RapidFill Implants inserted. The control arm will only have an EVAR device implanted.
For patients that choose to participate in the study in the treatment and control arms will be followed through 5 years post-procedure with visits at 30 days, 6 months, 1 year and annually thereafter through 5 years.REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0286
Date of REC Opinion
10 Jun 2024
REC opinion
Further Information Favourable Opinion