An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft

NCT03187522 | Terminated

• 1 other identifier: IP-0020-16
• Study Type: interventional
• Target: 174
• Locations: 7 countries
• Sites: 16

Brief Summary

This is an EU sponsored trial and independent of the US trial registered under Clinicaltrials.gov ID NCT02009644. The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.

Conditions

Aortic Aneurysm, Abdominal

Keywords

AAA; Abdominal Aortic Aneurysms

Outcome Measures

Primary Outcomes (8)

• Aneurysm-related mortality

  30 days post-procedure

• Stroke (excluding transient ischemic attack)

  30 days post-procedure

• Myocardial infarction

  Raised cardiac enzymes within 30 days of the procedure

  30 days post-procedure

• Renal failure

  Renal failure requiring renal replacement therapy (excluding renal insufficiency)

  30 days post-procedure

• Respiratory failure

  excluding chronic obstructive pulmonary disease or pulmonary complications)

  30 days post-procedure

• Paraplegia

  (excluding paraparesis)

  30 days post-procedure

• Bowel ischemia

  A restriction in blood supply to tissues in the bowels

  30 days post-procedure

• Treated aneurysm rupture

  30 days post-procedure

Secondary Outcomes (5)

• Major Adverse Events (MAE) at the follow-up time points

  30 days post-procedure

• Limb Ischemia

  30 days post-procedure

• Secondary procedures

  5 years

• Vascular access complications

  Vascular access will be evaluated on day of index procedure (implant)

• Patient-reported quality of life (QOL)

  One year follow-up

Study Arms (1)

TREO Stent-Graft

EXPERIMENTAL

Patients who receive a TREO Abdominal Stent-Graft System

Device: TREO Stent-Graft System

Interventions

TREO Stent-Graft System DEVICE

The TREO® Stent-Graft is designed for use in the management of patients with AAAs and is composed of self-expanding nitinol stents sutured to polyester vascular graft fabric.

TREO Stent-Graft

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Signed informed consent
• Willingness to comply with study follow-up
• Indication for elective endovascular repair
• Planned implantation of single Treo device system or aorto uni-iliac (AUI) device to include any auxiliary device components

You may not qualify if:

• Intolerance to contrast media
• Emergency procedure
• Chimneys or fenestrated device procedures
• Connective tissue disease (e.g., Marfan's syndrome)
• High probability of non-adherence to follow-up requirements
• Current participation in a concurrent trial that may confound study results
• Female of childbearing potential in whom pregnancy cannot be excluded
• Previous endovascular or surgical AAA repair

Sponsors & Collaborators

• Bolton Medical: lead
• Bolton Medical Espana SLU: collaborator

Study Sites (16)

Imelda Hospital

Bonheiden, 2820, Belgium

Location

Imeldaziekenhuis

Bonheiden, Belgium

Location

AZ Sint Blasius

Dendermonde, Belgium

Location

Bonifatius Hospital

Lingen, Germany

Location

University Clinic and St. Franziskus Hospital Muenster

Münster, D-48145, Germany

Location

University Hospital Tübingen

Tübingen, Germany

Location

Compensorio Sanitario Bolzano

Bolzano, Italy

Location

UMC Groningen

Groningen, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, Spain

Location

Centro Vascolare Ticino, Ospedale Regionale di Lugano

Lugano, 6903, Switzerland

Location

Civico, Ospedale Regionale

Lugano, Switzerland

Location

Addenbrooke's Hospital, Cambridge University Hospitals

Cambridge, United Kingdom

Location

Manchester Royal Infirmary, Central Manchester University Hospitals

Manchester, United Kingdom

Location

John Radcliffe Hospital, Oxford University Hospitals

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

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

Study Officials

• Giovanni Torsello, MD, PhD

  Center of Vascular and Endovascular Surgery, Munster University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, multi-center, post-market clinical follow-up, non-randomized registry of patients treated with the TREO stent-graft

Study Record Dates

• First Submitted: June 11, 2017
• First Posted: June 15, 2017
• Study Start: June 22, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 3, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); ES (2); GB (3); IT (1); BE (3); NL (2); DE (3)