Clinical trial NCT03414866: Thoraflex Hybrid Post-Market Study
Official title: Thoraflex Hybrid Post-Market Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Aortic Dissection
Aortic Rupture
Penetrating Aortic Ulcer
Aortic Dissection
Aortic Aneurysm, Thoracic
Keywords: Thoracic Aorta
Dissection
Aneurysm
Frozen Elephant Trunk
Lead sponsor: Vascutek Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-30
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Freedom from Major Adverse Event
timeFrame: 1 year post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Freiburg
country: Germany
facility: University of Freiburg
city: Hanover
country: Germany
facility: Hannover Medical School
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Nieuwegein
country: Netherlands
facility: St Antonious Hospital
Study officials:
affiliation: Hannover Medical School
name: Malakh Shrestha, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: