Thoraflex Hybrid and Relay Extension Post-Approval Study
- Conditions
- Thoracic DiseasesThoracic Aortic DissectionAortic AneurysmAortic DissectionThoracic Aortic Aneurysm
- Registration Number
- NCT05639400
- Lead Sponsor
- Vascutek Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint is a composite of the following: The primary safety endpoint will be measured again at least 8 months after the (first) extension procedure. * Permanent disabling stroke (mRS \>2 and an increase in at least one mRS category from the individual's pre-stroke baseline, occurring within 30 days of either index procedure or extension and present at 1-year follow-up)\*
* Grade 3 spinal cord ischemia (SVS reporting standards) occurring within 30 days of either index procedure or extension
* All-cause mortality (within 1 year of either procedure) (\*Per VARC-3, disability assessment using the mRS should be performed between 30 and 90 days after a neurological event with 90 days being optimal. An increased mRS score by itself and in the absence of a neurological event does not constitute stroke.)Primary Effectiveness Endpoint: Treatment Success The primary effectiveness endpoint will be measured again at least 8 months after the (first) extension procedure. Defined as device technical success (of either procedure) with absence of the following at 1-year:
* Lesion-related mortality (defined as all deaths occurring within 30 days of, or, prior to discharge, from either the index procedure or the extension procedure or any revision procedures to treat the original lesion(s) and any other deaths adjudicated by Clinical Events Committee as related or probably related to the lesion(s))
* Aortic rupture in the treated segment
* Lesion expansion (≥5mm increase from measurement at discharge/within 30 days)
* Secondary intervention to address the following:
* Stent graft-induced aortic wall injury (SAWI)
* Fistula
* Type I or III endoleak
* Migration
* Loss of Patency
* Thromboembolic events
* Failure of integrity
- Secondary Outcome Measures
Name Time Method Secondary effectiveness endpoints will be reported The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years. * Any aortic rupture (treated and untreated segments)
* Aortic remodeling in the treated segment(s)
* New dissections
* Proximal and distal extension of dissections
* Any false lumen perfusion (specifying location and if intentional or not)
* Fistula formation
* All endoleaks
* Device migration (measure both \>5mm from position at discharge/within 30 days, and \>10 mm from position at discharge/within 30 days, and requiring secondary intervention)
* Device integrity issues (e.g., stent fracture)
* All thromboembolic events
* Pseudoaneurysms (device-related)
* Secondary Interventions
* Graft patency (loss of patency will be defined as an opening of \<50% due to, for example, occlusion, stenosis, kinking)Secondary Safety Endpoints, Absence of the following The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years. * All-cause mortality, and
* Lesion-related mortality (defined as all deaths occurring within 30 days of, or, prior to discharge, from either the index procedure or the extension procedure or any revision procedures to treat the original lesion(s) and any other deaths adjudicated by Clinical Events Committee as related or probably related to the lesion(s))
* All/any paraplegia/paraparesis defined as SCI (SVS grades 1 to 3)
* Any stroke (excluding TIA)
* Incidence of Myocardial Infarction
* Incidence of Respiratory Failure
* Incidence of Renal Failure
* Incidence of Bowel Ischemia
Trial Locations
- Locations (25)
University of Alabama in Birmingham Medical Center
🇺🇸Birmingham, Alabama, United States
Cedars-Sinai Medical Centre
🇺🇸Los Angeles, California, United States
Keck Medical Centre of USC
🇺🇸Los Angeles, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Medstar Washington Hospital Centre
🇺🇸Washington, District of Columbia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Ascension St. Vincent Heart Center
🇺🇸Indianapolis, Indiana, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Washington University/Barnes Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Weill Cornell medicine
🇺🇸New York, New York, United States
Duke University Medical Centre
🇺🇸Durham, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UT Dell Medical / Ascension Texas Cardiovascular
🇺🇸Austin, Texas, United States
Baylor College of Medicine - St. Luke's
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Paracelsus Medical University
🇦🇹Salzburg, Austria
CHU Nantes
🇫🇷Saint-Herblain, France
CHU de Toulouse - Hôpital de Rangueil
🇫🇷Toulouse, France
University of Freiburg
🇩🇪Freiburg, Germany
Policlinico Di S.Orsola, Universita' Di Bologna
🇮🇹Bologna, Italy
Hospital Clinic of Barcelona
🇪🇸Barcelona, Spain
Oxford University Hospitals NHS FT
🇬🇧Oxford, United Kingdom