INSIGHT study - Protocol Number: P13-4601
Research type
Research Study
Full title
A Multicenter, Open Label, Prospective, Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects with Abdominal Aortic Aneurysms
IRAS ID
181536
Contact name
Christopher Jason Wilkins
Contact email
Sponsor organisation
CORDIS CORPORATION
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 30 days
Research summary
Research Summary
This is a multi-center prospective, open label, post approval investigation of INCRAFT® in subjects with abdominal aortic aneurysm large enough to require repair.
An abdominal aortic aneurysm is an enlarged part of the large blood vessel, the aorta, in the region between the chest and groin. The aorta carries blood pumped from the heart to the lower parts of the body, including the legs. Because the vessel wall of an aortic aneurysm is weak the vessel has a risk of rupturing in the abdomen, causing internal bleeding. This is usually a fatal occurrence without treatment. Traditional treatment is open surgery which carries significant risks in often elderly patients. If the aneurysm is detected before rupture, for example on examination by a doctor or by an ultrasound scan, treatment to repair the aneurysm is offered where possible once the aneurysm reaches a size where there is a significant chance of rupture.
An alternative to surgery is a ‘stent graft’ device. This is a metal expanding tube (the stent) covered in material (the graft) which relines the aneurysmal aortic segment creating a seal above and below the aneurysm while allowing blood to flow freely to the lower body. The aneurysm is effectively ‘depressurised’ and rupture is prevented.
A stent graft device is inserted using catheter based ‘endovascular’ technology. This is a “minimally invasive” method of carrying out procedures on blood vessels within the body. Combinations of small wires and catheters are used along with xray guidance to perform a variety of procedures. This technology has been adapted to enable treatment of abdominal aortic aneurysms with special ‘stent graft’ systems which can be inserted through small incisions at the groins via the blood vessels there. This has benefits in terms of fewer operative complications and reduced recovery times when compared to traditional open surgery. This system is designed to seal tightly with artery above and below the aneurysm: it is stronger than the weakened blood vessel and allows blood to pass through it, preventing the aneurysm from growing bigger and eventually rupturing.
The purpose of this study is to collect information on the safety and performance of INCRAFT® aortic stent graft within 30days post-procedure in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice.
The study will enroll 150 subjects at up to 25 study sites in Europe. The study will be conducted in 4 sites in the UK all based in NHS Trust hospitals.
Study data will be collected from patients treated with INCRAFT.
Treatment will follow routine clinical practice although there is a study requirement of two X-rays (within 30 days and at 1 year follow up after procedure). Institutional follow up varies and these x-rays may not be part of routine follow up but are required as part of the study in order to assess device migration and fracture rates.
Study data will be collected on the subject’s medical history; periprocedurally; during the index hospitalization, and during routine annual follow-up up to 5 years after procedure.Summary of Results
There were 150 subjects enrolled in this trial at 23 sites across Europe from 30/Mar/2015 to 15/Sep/2016. Subjects were eligible for entry into INSIGHT if they met the protocol-defined eligibility criteria. Last subject visit occurred on 09/Dec/2021. This report is based on data exported from the main study database on 03/Feb/2022 and provided by the core laboratory on 04/Jan/2018. A favorable safety profile was demonstrated in this study through the absence of major AEs within 30 days of the procedure, achieving the primary endpoint (absence of major adverse events (death, myocardial infarction (heart attack), stroke/Cerebral vascular accident, and renal failure) with 100% success. Effectiveness was demonstrated by the technical success of the index procedure and successful aneurysm repair at one year. The results of the study support the safety and effectiveness of the INCRAFT AAA Stent Graft System when used in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice.
REC name
West of Scotland REC 3
REC reference
15/WS/0147
Date of REC Opinion
19 Aug 2015
REC opinion
Further Information Favourable Opinion