Thoraflex Hybrid Post-Market Study

NCT03414866 | Active Not Recruiting

• 1 other identifier: THOR-001
• Study Type: observational
• Target: 182
• Locations: 4 countries
• Sites: 7

Brief Summary

This is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic aneurysm.

Conditions

Acute Aortic Dissection; Aortic Rupture; Penetrating Aortic Ulcer; Aortic Dissection; Aortic Aneurysm, Thoracic

Keywords

Thoracic Aorta; Dissection; Aneurysm; Frozen Elephant Trunk

Outcome Measures

Primary Outcomes (1)

• Freedom from Major Adverse Event

  The primary endpoint will be freedom from the following composite Major Adverse Event (MAE): permanent stroke , permanent paraplegia/paraparesis, unanticipated aortic related re-operation (excluding re-operation for bleeding) and aortic related mortality

  1 year post-procedure

Study Arms (3)

Acute thoracic aortic syndrome

60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire

Behavioral: EQ-5D-5L QOL questionnaire

Subacute/chronic dissection of the aorta

60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire

Behavioral: EQ-5D-5L QOL questionnaire

Aortic aneurysm

60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire

Behavioral: EQ-5D-5L QOL questionnaire

Interventions

EQ-5D-5L QOL questionnaire BEHAVIORAL

Written questionnaire

Acute thoracic aortic syndrome; Aortic aneurysm; Subacute/chronic dissection of the aorta

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

60 patients with acute thoracic aortic syndrome, including: acute dissection, aortic rupture and penetrating aortic ulcer (PAU) 60 patients with a subacute/chronic dissection of the aorta 60 patients with an aortic aneurysm

You may qualify if:

• Patient is aged 18 years or over on date of consent
• Patient is willing and able to comply with all study procedures and study visits
• Patient or their legally authorised representative (LAR) has given written informed consent to participate in study. For emergency patients only, retrospective consent is permissible
• A - Patient has acute thoracic aortic syndrome or B - Patient has subacute/ chronic dissection of the aorta or C - Patient has an aortic aneurysm (including connective tissue disorders)
• A. Patients with acute thoracic aortic syndrome:
• Patient has acute thoracic aortic syndrome and requires repair or replacement of damaged or diseased vessels of the aortic arch (with or without involvement of the ascending aorta), and the descending aorta requires replacement, or, in the opinion of the investigator, the patient would derive clinical benefit from prophylactic treatment of the descending aorta. This includes patients with acute dissections, rupture of the aorta or PAU.
• B. Patients with subacute/chronic dissection of the aorta:
• Patient requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta due to subacute/chronic dissection.
• And patient satisfies one or more of the following criteria:
• Patient has aortic sinus, or ascending aorta, or aortic arch, or descending aorta diameter ≥5.5cm (including if asymptomatic) or
• Patient has aorta diameter \<5.5cm and growth rate ≥0.5cm/year (including if asymptomatic) or
• Patient has ascending aorta diameter ≥4.5cm and requires valve repair or replacement
• C. Patients with an aortic aneurysm (including connective tissue disorders):
• Patient requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta
• And patient satisfies one or more of the following criteria:

You may not qualify if:

• Patient is unfit for open surgical repair involving circulatory arrest
• Patient has known sensitivity to polyester, nitinol or materials of bovine origin
• Patient has active endocarditis or an active infective disorder of the aorta
• Patient has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
• Patient is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study, which in the opinion of the Investigator will impact on this study
• Patient has an uncorrectable bleeding anomaly
• Patient has renal failure (defined as dialysis dependent)
• Patient has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated
• Patient has a co-morbidity causing expected survival to be less than 1 year
• Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure

Sponsors & Collaborators

• Vascutek Ltd.: lead

Study Sites (7)

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

University of Freiburg

Freiburg im Breisgau, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

Policlinico S.Orsola-Malpighi

Bologna, Italy

Location

St Antonious Hospital

Nieuwegein, Netherlands

Location

MeSH Terms

Conditions

Aortic Rupture; Penetrating Atherosclerotic Ulcer; Aortic Dissection; Aortic Aneurysm, Thoracic; Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm, Ruptured; Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Aortic Diseases; Rupture; Wounds and Injuries; Acute Aortic Syndrome; Arteriosclerosis; Arterial Occlusive Diseases; Dissection, Blood Vessel

Study Officials

• Malakh Shrestha, Prof. Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: May 25, 2018
• Primary Completion: April 25, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

IT (1); NL (1); CA (3); DE (2)