Thoraflex™ Hybrid IDE Study

Completed · Not applicable

Conditions studied: Aortic Aneurysm, Aortic Dissection, Aortic Rupture

In brief

The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of ascending aorta. The study will also assess safety and early clinical outcomes in patients who receive an extension procedure within 1 year of Thoraflex™ Hybrid Device implantation. Lastly the study will assess the safety and clinical outcomes of patients who receive a Thoraflex™ Hybrid Device for treatment of a ruptured aorta. Patients will be followed for 3 years. The Primary Endpoint will be freedom from defined Major Adverse Events (MAE) occurring ≤ 1 year post-procedure.

Key facts

Study ID

NCT02724072

Run by

Bolton Medical

People needed

84

Starts

2016-08-22

Expected to finish

2021-07-30

Last updated by the study team

2022-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Main Study Group (All patients except Aortic Rupture Patients)
• 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 authorized representative has given written informed consent to participate in study
• Patient satisfies the inclusion criteria for one of the following categories:
• A - Patient has acute dissection of the aorta or B - Patient has chronic dissection of the aorta or C - Patient has an aortic aneurysm (including connective tissue disorders)
• A. - Patients with acute dissection of the aorta:
• Patient has acute aortic dissection 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.
• B. - Patients with 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 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
• Inclusion criteria for Patients with Ruptured Aorta only:
• Patient is aged 18 years or over, on date of consent
• Patient or their legally authorized representative is able and willing to give consent to the patient's enrolment in the study
• Patient has either a ruptured thoracic aorta, or, in the experience of the treating surgeon, is at high risk of imminent rupture of the thoracic aorta

You may not qualify if…

• Main Study Group (All Patients Except Patients with Ruptured Aorta)
• Patient is unfit for open surgical repair involving circulatory arrest
• Patient has known sensitivity to polyester, nitinol or materials of bovine origin
• Patient has a ruptured aorta
• 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
• Patient is female and is pregnant, or planning to become pregnant during the course of the study. Females of childbearing potential must use acceptable methods of contraception.
• Patient has an uncorrectable bleeding anomaly
• Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.5mg/dL)
• 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
• Exclusion criteria for Patients with Ruptured Aorta only:
• Patient has chronic dissection which, in the opinion of the investigator, can be treated electively
• Patient has aneurysmal disease which, in the opinion of the investigator, can be treated electively

Where it is running

• Stanford University Medical Center — Palo Alto, California, United States
• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• The Mount Sinai Hospital — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• NY Presbyterian Weill Cornell — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center (UPMC) Presbyterian — Pittsburgh, Pennsylvania, United States
• Baylor St. Luke's — Houston, Texas, United States
• University of Texas Houston- Memorial Hermann Texas Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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