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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03180996




Registration number
NCT03180996
Ethics application status
Date submitted
24/05/2017
Date registered
8/06/2017
Date last updated
22/06/2023

Titles & IDs
Public title
Global Fenestrated Anaconda Clinical sTudy
Scientific title
A Prospective, Global, Multicentre, Real World Outcome Study of Fenestrated Endovascular Aneurysm Repair Using the Fenestrated Anaconda™ Device
Secondary ID [1] 0 0
FACT-001
Universal Trial Number (UTN)
Trial acronym
Global FACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System

Treatment: Devices: Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System
Fenestrated Endovascular Aortic Repair (FEVAR)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients who experience Treatment Success.
Timepoint [1] 0 0
1 year post-procedure

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Epworth Richmond Private Hospital - Melbourne
Recruitment hospital [2] 0 0
Hollywood Medical Centre - Perth
Recruitment postcode(s) [1] 0 0
3121 - Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Netherlands
State/province [3] 0 0
Arnhem
Country [4] 0 0
Netherlands
State/province [4] 0 0
Enschede
Country [5] 0 0
Netherlands
State/province [5] 0 0
Groningen
Country [6] 0 0
Netherlands
State/province [6] 0 0
Nieuwegein
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Tyne And Wear
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Camberley
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vascutek Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03180996
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clark J Zeebregts, MD, PhD, Prof
Address 0 0
Universitair Medisch Centrum Groningen (UMCG), Netherlands
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03180996