Abdominal Aortic AneurysmGlobal FACTNCT03180996
Global Fenestrated Anaconda Clinical STudy
An observational study of Abdominal Aortic Aneurysm, run by Vascutek Ltd. at 11 sites in 5 countries.
Trial summary
This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda™ system, and is essentially a post-market study. The Vascutek Fenestrated Anaconda™ system is a custom made device used for the treatment of Abdominal Aortic Aneurysm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 11 Sep 2017to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a juxtrarenal or suprarenal abdominal aortic aneurysm, including those aneurysms with very short neck or no neck, who require endovascular repair of their aneurysm and whose aneurysm is suitable for treatment using a custom made Vascutek Fenestrated Anaconda™ device will be recruited. This is a non-interventional study and therefore only patients who would normally receive this device as part of standard treatment at the participating institute will be recruited.
Who may be able to join
- Patients must meet all of the criteria below in order to be eligible for inclusion in the study -
- Patient is aged 18 years or over on the date of consent
- Patient is willing and able to comply with all study procedures and study follow-up visits
- Patient is willing and able to give written informed consent to participate in study
- Patient has a juxtrarenal or suprarenal abdominal aortic aneurysm (AAA) with maximum sac diameter ≥ 5.5cm, or an AAA ≥ 4.5 cm which has increased by > 1.0 cm in the past year
- Patient is anatomically suitable for a bifurcated Fenestrated Anaconda™ device
- NOTE: Both the treating Investigator and the Manufacturer must agree that the proposed patient's anatomy is suitable for treatment using the Fenestrated Anaconda™ device. Where the Investigator proposes that the patient anatomy is suitable and the Manufacturer subsequently disagrees, the patient will be recorded as a screen failure and deemed not eligible for the study.
Who cannot join
- Any patient who meets any of the criteria below will be excluded from participation in the study -
- Patient has a life expectancy < 2 years, as judged by the Investigator
- Patient has psychiatric or other condition that in the opinion of the Investigator may limit their ability to comply with study procedures
- Patient is participating in another clinical study which in the opinion of the Investigator could influence the outcomes of this study
- Patient has a known allergy to any device component (polyester, nitinol, nickel)
- Patient has a coagulopathy or uncontrolled bleeding disorder
Show all 12Show fewer
- Patient has a ruptured, leaking or mycotic aneurysm
- Patient has a serum creatinine (S-Cr) level > 2.0 mg/dL (177 µmol/L)
- Patient has had CVA or MI within three months of enrolment or treatment
- Patient has a connective tissue disease (e.g. Marfan Syndrome)
- Patient has had a previously inserted endovascular stent in the abdominal aorta
- Patient is pregnant (female of childbearing potential only)
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Netherlands4 sites
Rijnstate Hospital
Arnhem, 6815 AD
Medisch Spectrum Twente (MST)
Enschede, 7512 EZ
Universitair Medisch Centrum Groningen (UMCG)
Groningen, G713 GZ
Antonius Ziekenhuis
Nieuwegein, 3435 CM
United Kingdom3 sites
Frimley Park Hospital
Camberley, GU16 7UJ
Imperial College, St Mary's Hospital
London, W2 1NY
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Australia2 sites
Epworth Richmond Private Hospital
Melbourne, Victoria, 3121
Hollywood Medical Centre
Perth, Western Australia, 6009
About this study
Official title: A Prospective, Global, Multicentre, Real World Outcome Study of Fenestrated Endovascular Aneurysm Repair Using the Fenestrated Anaconda™ Device
This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda™ system, and is essentially a post-market study. The Vascutek Fenestrated Anaconda™ system is a custom made device used for the treatment of Abdominal Aortic Aneurysm.
Read the detailed description
Abdominal Aortic Aneurysm (AAA) is a life threatening disease. Endovascular repair of infrarenal abdominal aortic aneurysms (EVAR) has replaced open surgical repair as the standard of care treatment for most patients. Endovascular repair offers several benefits over open surgical repair, including: less invasive procedure, faster recovery, lower morbidity and lower early post-operative mortality. The configuration of vascular anatomy is important to the successful placement and subsequent performance of infrarenal EVAR devices. In particular aortic neck angulation and length are important for the success of EVAR. Challenging necks with an aortic diameter ≥28 mm, angulation ≥60°, length <10mm, circumferential thrombus, reversed tapered configuration or neck with bulging, make it more difficult to oppose the endograft to the aortic wall and are related to an increased risk of type Ia endoleak and reinterventions. In order to overcome these issues, fenestrated and branched stent grafts have been developed. Fenestrated and branched endovascular aneurysm repair is now a routinely utilised procedure in the treatment of complex aortic aneurysm anatomy, especially in patients unsuitable for open surgical repair.
The Fenestrated Anaconda™ device (Vascutek Ltd, Glasgow, Scotland, UK) has been commercially available since 2010. The Fenestrated Anaconda™ device has potential advantages over other FEVAR devices, since it can be repositioned after deployment, has a magnet-assisted limb cannulation, and the device contains less metal, allowing a better view of the radiological markers on the device during intra-operative imaging. Additionally, the potential to position fenestrations anywhere in the main body is unrestricted due to the absence of other stent structures.
This prospective, real world study of the Fenestrated Anaconda™ device will provide insight into both the short and long term clinical outcomes of the device. An attempt will be made to identify predictors of success or failure, and this study will help to identify patients that are likely to benefit from repair and improve results. The effect of FEVAR on post-operative patient reported quality of life will be assessed. In addition, the study will provide insight into the potential decline in renal function after FEVAR, a well-known concern after both EVAR and FEVAR.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System
- Keywords
- FEVAR, Fenestrated, Endovascular, AAA, Custom device
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft SystemDevice
Fenestrated Endovascular Aortic Repair (FEVAR)
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who experience Treatment Success.
Treatment success is defined as freedom from the following: Type I and III endoleak; stent graft migration; AAA enlargement; AAA rupture; conversion to open surgery; non-patent endoluminal grafts and/or significant twists, kinks or obstruction; aneurysm-related patient death.
Measured: 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start11 Sep 2017
- Primary completion31 Mar 2022
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clark J Zeebregts, MD, PhD, Prof, Principal investigator, Universitair Medisch Centrum Groningen (UMCG), NetherlandsMichel MPJ Reijnen, MD, PhD, Prof, Principal investigator, Rijnstate Hospital, Arnhem, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180996
- Sponsor's protocol ID
- FACT-001
- Acronym
- Global FACT
- Status last verified
- Dec 2024
- First submitted
- 24 May 2017
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Global, Multicentre, Real World Outcome Study of Fenestrated Endovascular Aneurysm Repair Using the Fenestrated Anaconda™ Device
- ClinicalTrials.gov ID
- NCT03180996
- Acronym / sponsor ID
- Global FACT / FACT-001
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- FEVAR, Fenestrated, Endovascular, AAA, Custom device
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda™ system, and is essentially a post-market study. The Vascutek Fenestrated Anaconda™ system is a custom made device used for the treatment of Abdominal Aortic Aneurysm.
Detailed description
Abdominal Aortic Aneurysm (AAA) is a life threatening disease. Endovascular repair of infrarenal abdominal aortic aneurysms (EVAR) has replaced open surgical repair as the standard of care treatment for most patients. Endovascular repair offers several benefits over open surgical repair, including: less invasive procedure, faster recovery, lower morbidity and lower early post-operative mortality. The configuration of vascular anatomy is important to the successful placement and subsequent performance of infrarenal EVAR devices. In particular aortic neck angulation and length are important for the success of EVAR. Challenging necks with an aortic diameter ≥28 mm, angulation ≥60°, length <10mm, circumferential thrombus, reversed tapered configuration or neck with bulging, make it more difficult to oppose the endograft to the aortic wall and are related to an increased risk of type Ia endoleak and reinterventions. In order to overcome these issues, fenestrated and branched stent grafts have been developed. Fenestrated and branched endovascular aneurysm repair is now a routinely utilised procedure in the treatment of complex aortic aneurysm anatomy, especially in patients unsuitable for open surgical repair.
The Fenestrated Anaconda™ device (Vascutek Ltd, Glasgow, Scotland, UK) has been commercially available since 2010. The Fenestrated Anaconda™ device has potential advantages over other FEVAR devices, since it can be repositioned after deployment, has a magnet-assisted limb cannulation, and the device contains less metal, allowing a better view of the radiological markers on the device during intra-operative imaging. Additionally, the potential to position fenestrations anywhere in the main body is unrestricted due to the absence of other stent structures.
This prospective, real world study of the Fenestrated Anaconda™ device will provide insight into both the short and long term clinical outcomes of the device. An attempt will be made to identify predictors of success or failure, and this study will help to identify patients that are likely to benefit from repair and improve results. The effect of FEVAR on post-operative patient reported quality of life will be assessed. In addition, the study will provide insight into the potential decline in renal function after FEVAR, a well-known concern after both EVAR and FEVAR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a juxtrarenal or suprarenal abdominal aortic aneurysm, including those aneurysms with very short neck or no neck, who require endovascular repair of their aneurysm and whose aneurysm is suitable for treatment using a custom made Vascutek Fenestrated Anaconda™ device will be recruited. This is a non-interventional study and therefore only patients who would normally receive this device as part of standard treatment at the participating institute will be recruited.
Key inclusion criteria (7 listed)
- Patients must meet all of the criteria below in order to be eligible for inclusion in the study -
- Patient is aged 18 years or over on the date of consent
- Patient is willing and able to comply with all study procedures and study follow-up visits
- Patient is willing and able to give written informed consent to participate in study
- Patient has a juxtrarenal or suprarenal abdominal aortic aneurysm (AAA) with maximum sac diameter ≥ 5.5cm, or an AAA ≥ 4.5 cm which has increased by > 1.0 cm in the past year
Key exclusion criteria (12 listed)
- Any patient who meets any of the criteria below will be excluded from participation in the study -
- Patient has a life expectancy < 2 years, as judged by the Investigator
- Patient has psychiatric or other condition that in the opinion of the Investigator may limit their ability to comply with study procedures
- Patient is participating in another clinical study which in the opinion of the Investigator could influence the outcomes of this study
- Patient has a known allergy to any device component (polyester, nitinol, nickel)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft SystemFenestrated Endovascular Aortic Repair (FEVAR) | Device | – |
Primary outcome
Proportion of patients who experience Treatment Success.
Time frame: 1 year post-procedure
Treatment success is defined as freedom from the following: Type I and III endoleak; stent graft migration; AAA enlargement; AAA rupture; conversion to open surgery; non-patent endoluminal grafts and/or significant twists, kinks or obstruction; aneurysm-related patient death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clark J Zeebregts, MD, PhD, Prof principal investigator
Universitair Medisch Centrum Groningen (UMCG), Netherlands
Michel MPJ Reijnen, MD, PhD, Prof principal investigator
Rijnstate Hospital, Arnhem, Netherlands
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Vascutek Ltd. at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands, United Kingdom, Australia, Austria, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who experience Treatment Success. (time frame: 1 year post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.