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Thoraflex Hybrid Post-Market Study (THOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414866
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Vascutek Ltd.

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.

Condition or disease Intervention/treatment
Acute Aortic Dissection Aortic Rupture Penetrating Aortic Ulcer Aortic Dissection Aortic Aneurysm, Thoracic Behavioral: EQ-5D-5L QOL questionnaire

Detailed Description:

Aortic arch pathologies are rare, but pose significant challenges for treatment involving open surgical or endovascular repair.

In 1983 the Elephant Trunk technique was introduced and has greatly facilitated the management of patients with extensive thoracic aortic disease.

In recent years, this traditional open surgery has been combined with thoracic endovascular repair (TEVAR) and this is known as the 'hybrid' approach. Hybrid repairs, consisting of an open surgical repair combined with endovascular techniques.

Further advancement in the types of prosthesis available has resulted in the evolution of the conventional ET technique into the frozen elephant trunk (FET) technique. This utilises devices that incorporate both a traditional dacron graft (for open surgical treatment of the aortic arch) and a stented graft portion (for treatment of the descending thoracic aorta). The stented portion of the graft is introduced via an antegrade approach through the transected arch. The FET technique is now commonly used to treat patients with extensive thoracic or thoraco-abdominal aortic disease.

Vascutek Ltd has developed the Thoraflex™ Hybrid Device (Plexus™ 4 and Ante-Flo™) for the repair or replacement of damaged or diseased vessels of the ascending aorta, aortic arch and descending thoracic aorta in cases of aneurysm and/or dissection. The Thoraflex™ Hybrid Device is one of the commercially available frozen elephant trunk prosthesis.

Over 3000 Thoraflex™ Hybrid Devices have been sold and the current study seeks to provide further evidence of the continuing safety and effectiveness of the device.

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thoraflex Hybrid Post-Market Study
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Group/Cohort Intervention/treatment
Acute thoracic aortic syndrome
60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire
Behavioral: EQ-5D-5L QOL questionnaire
Written 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
Written questionnaire

Aortic aneurysm
60 patients, standard of care (non-interventional) EQ-5D-5L QOL Questionnaire
Behavioral: EQ-5D-5L QOL questionnaire
Written questionnaire




Primary Outcome Measures :
  1. Freedom from Major Adverse Event [ Time Frame: 1 year post-procedure ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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

Criteria

Inclusion Criteria:

  • 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
  • Patient satisfies the inclusion criteria for one of the following categories:

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:

  • 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.

or

  • Patient has Marfan syndrome or other genetically mediated disorders with aortic sinus, or ascending aorta, or arch diameter ≥4.5cm, or, the ratio of the maximal ascending or aortic root area (Π r2) in cm2 divided by the patient's height in meters exceeds 10

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414866


Contacts
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Contact: Jill Bryson +44 141 812 5555 j.bryson@vascutek.com
Contact: Sarah Thomas +44 141 812 5555 S.Thomas@vascutek.com

Locations
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Canada, Ontario
London Health Sciences Centre, University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Stephanie Fox         
Principal Investigator: Michael Chu, MD, FRCSC         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada
Contact: Jacqueline Fortier         
Principal Investigator: Munir Boodhwani, Dr         
Toronto General Hospital Recruiting
Toronto, Ontario, Canada
Contact: Daniella Eliathamby         
Principal Investigator: Maral Ouzounian, Dr         
Germany
University of Freiburg Recruiting
Freiburg, Germany
Contact: Gabrielle Lechner         
Principal Investigator: Martin Czerny, Prof         
Hannover Medical School Recruiting
Hanover, Germany, 30625
Principal Investigator: Malakh Shrestha, Prof. Dr.         
Italy
Policlinico S.Orsola-Malpighi Not yet recruiting
Bologna, Italy
Contact: Alessandro Leone, Dr         
Principal Investigator: Roberto Di Bartolomeo, Professor         
Netherlands
St Antonious Hospital Recruiting
Nieuwegein, Netherlands
Contact: Jelle Fleerakkers         
Principal Investigator: Robin H Heijmen, Dr         
Sponsors and Collaborators
Vascutek Ltd.
Investigators
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Principal Investigator: Malakh Shrestha, Prof. Dr. Hannover Medical School
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Responsible Party: Vascutek Ltd.
ClinicalTrials.gov Identifier: NCT03414866    
Other Study ID Numbers: THOR-001
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vascutek Ltd.:
Thoracic Aorta
Dissection
Aneurysm
Frozen Elephant Trunk
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aneurysm, Dissecting
Aortic Aneurysm, Thoracic
Aortic Rupture
Rupture
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries
Aneurysm, Ruptured