Global Fenestrated Anaconda Clinical STudy

NCT03180996 | Active Not Recruiting

• 1 other identifier: FACT-001
• Study Type: observational
• Target: 160
• Locations: 4 countries
• Sites: 9

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

FEVAR; Fenestrated; Endovascular; AAA; Custom device

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year post-procedure

Interventions

Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System DEVICE

Fenestrated Endovascular Aortic Repair (FEVAR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Vascutek Ltd.: lead

Study Sites (11)

Epworth Richmond Private Hospital

Melbourne, Victoria, 3121, Australia

Location

Hollywood Medical Centre

Perth, Western Australia, 6009, Australia

Location

Wilhelminenspital

Vienna, 1160, Austria

Location

Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

Location

Medisch Spectrum Twente (MST)

Enschede, 7512 EZ, Netherlands

Location

Universitair Medisch Centrum Groningen (UMCG)

Groningen, G713 GZ, Netherlands

Location

Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Freeman Hospital

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

Location

Frimley Park Hospital

Camberley, GU16 7UJ, United Kingdom

Location

Imperial College, St Mary's Hospital

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Clark J Zeebregts, MD, PhD, Prof

  Universitair Medisch Centrum Groningen (UMCG), Netherlands

  PRINCIPAL INVESTIGATOR

• Michel MPJ Reijnen, MD, PhD, Prof

  Rijnstate Hospital, Arnhem, Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 8, 2017
• Study Start: September 11, 2017
• Primary Completion: March 31, 2022
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); AU (1); NL (4); CA (1)