Clinical trial NCT05639400: Thoraflex Hybrid and Relay Extension Post-Approval Study
Official title: Thoraflex Hybrid and Relay Extension Post-Approval Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Diseases
Aortic Aneurysm
Aortic Dissection
Thoracic Aortic Aneurysm
Thoracic Aortic Dissection
Keywords: TEVAR
Frozen Elephant Trunk (FET)
Lead sponsor: Vascutek Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Bolton Medical
First posted: 2022-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft.

Brief summary: The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta.

Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site.

Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.


Eligibility criteria: Inclusion Criteria:

Patient is aged 18 years or older on date of consent. Patient is willing and able to comply with all study procedures and visits. Patient or their next of kin (NOK)/legally designated representative (LDR) has given written informed consent to participate in the study.

Patient will undergo treatment with a Thoraflex Hybrid device. If a patient requires an extension procedure due to the extent of aortic disease, a RelayPro NBS Stent-graft should be placed inside the distal end of the previously placed Thoraflex Hybrid device via a retrograde approach. This may be part of the same or a two-stage procedure.

Exclusion Criteria:

* Patient has any 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: Primary Safety Endpoint is a composite of the following:
timeFrame: The primary safety endpoint will be measured at one-year after the index procedure and again at least 8 months after the (first) extension procedure.
measure: Primary Safety Endpoint is a composite of the following:
timeFrame: The primary safety endpoint will be measured again at least 8 months after the (first) extension procedure.
measure: Primary Effectiveness Endpoint: Treatment Success
timeFrame: The primary effectiveness endpoint will be measured at one-year after the index procedure.
measure: Primary Effectiveness Endpoint: Treatment Success
timeFrame: The primary effectiveness endpoint will be measured again at least 8 months after the (first) extension procedure.
Secondary outcomes:
measure: Secondary Safety Endpoints, Absence of the following
timeFrame: The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years.
measure: Secondary effectiveness endpoints will be reported
timeFrame: The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama in Birmingham Medical Center
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Centre
state: California
city: Los Angeles
country: United States
facility: Keck Medical Centre of USC
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: Medstar Washington Hospital Centre
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Ascension St. Vincent Heart Center
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University/Barnes Jewish Hospital
state: Missouri
city: New York
country: United States
facility: Weill Cornell medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Centre
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Austin
country: United States
facility: UT Dell Medical / Ascension Texas Cardiovascular
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - St. Luke's
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Salzburg
country: Austria
facility: Paracelsus Medical University
city: Saint-Herblain
country: France
facility: CHU Nantes
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital de Rangueil
city: Freiburg
country: Germany
facility: University of Freiburg
city: Bologna
country: Italy
facility: Policlinico Di S.Orsola, Universita' Di Bologna
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS FT
Study officials:
affiliation: University of Freiburg
name: Martin Czerny
role: PRINCIPAL_INVESTIGATOR
affiliation: Jefferson Health and Sidney Kimmel Medical College
name: Joseph E Bavaria
role: PRINCIPAL_INVESTIGATOR
References: