Global Fenestrated Anaconda Clinical sTudy (Global FACT)

• ClinicalTrials.gov Identifier: NCT03180996
• Recruitment Status: Active, not recruiting
• First Posted: June 8, 2017
• Last Update Posted: April 28, 2022
• Sponsor: Vascutek Ltd.
• Information provided by (Responsible Party): Vascutek Ltd.

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Abdominal Aortic Aneurysm	Device: Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System

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

• Study Type: Observational
• Estimated Enrollment: 160 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Global, Multicentre, Real World Outcome Study of Fenestrated Endovascular Aneurysm Repair Using the Fenestrated Anaconda™ Device
• Actual Study Start Date: September 11, 2017
• Actual Primary Completion Date: March 31, 2022
• Estimated Study Completion Date: December 31, 2030

Groups and Cohorts

Intervention Details:

• Device: Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System
  Fenestrated Endovascular Aortic Repair (FEVAR)

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

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.

Criteria

Inclusion Criteria:

Patients must meet all of the criteria below in order to be eligible for inclusion in the study -

1. Patient is aged 18 years or over on the date of consent
2. Patient is willing and able to comply with all study procedures and study follow-up visits
3. Patient is willing and able to give written informed consent to participate in study
4. 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
5. 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.

Exclusion Criteria:

Any patient who meets any of the criteria below will be excluded from participation in the study -

1. Patient has a life expectancy < 2 years, as judged by the Investigator
2. Patient has psychiatric or other condition that in the opinion of the Investigator may limit their ability to comply with study procedures
3. Patient is participating in another clinical study which in the opinion of the Investigator could influence the outcomes of this study
4. Patient has a known allergy to any device component (polyester, nitinol, nickel)
5. Patient has a coagulopathy or uncontrolled bleeding disorder
6. Patient has a ruptured, leaking or mycotic aneurysm
7. Patient has a serum creatinine (S-Cr) level > 2.0 mg/dL (177 µmol/L)
8. Patient has had CVA or MI within three months of enrolment or treatment
9. Patient has a connective tissue disease (e.g. Marfan Syndrome)
10. Patient has had a previously inserted endovascular stent in the abdominal aorta
11. Patient is pregnant (female of childbearing potential only)

Contacts and Locations

Locations

Australia, Victoria

Epworth Richmond Private Hospital

Melbourne, Victoria, Australia, 3121

Australia, Western Australia

Hollywood Medical Centre

Perth, Western Australia, Australia, 6009

Austria

Wilhelminenspital

Vienna, Austria, 1160

Canada, Alberta

Peter Lougheed Centre

Calgary, Alberta, Canada, T1Y 6J4

Netherlands

Rijnstate Hospital

Arnhem, Netherlands, 6815 AD

Medisch Spectrum Twente (MST)

Enschede, Netherlands, 7512 EZ

Universitair Medisch Centrum Groningen (UMCG)

Groningen, Netherlands, G713 GZ

Antonius Ziekenhuis

Nieuwegein, Netherlands, 3435 CM

United Kingdom

Freeman Hospital

Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN

Frimley Park Hospital

Frimley, Camberley, United Kingdom, GU16 7UJ

Imperial College, St Mary's Hospital

London, United Kingdom, W2 1NY

Sponsors and Collaborators

Vascutek Ltd.

Investigators

• Principal Investigator: Clark J Zeebregts, MD, PhD, Prof; Universitair Medisch Centrum Groningen (UMCG), Netherlands
• Principal Investigator: Michel MPJ Reijnen, MD, PhD, Prof; Rijnstate Hospital, Arnhem, Netherlands

More Information

• Responsible Party: Vascutek Ltd.
• ClinicalTrials.gov Identifier: NCT03180996
• Other Study ID Numbers: FACT-001
• First Posted: June 8, 2017
• Last Update Posted: April 28, 2022
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vascutek Ltd.:

FEVAR; Fenestrated; Endovascular; AAA; Custom device

Additional relevant MeSH terms:

Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases