Clinical trial NCT06507865: Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis
Official title: Characterization of Mid-term Post Market Clinical Follow Up of GORE® TAG® Thoracic Branch Endoprosthesis Facilitated Aortic Arch and Descending Aorta Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aneurysm
Dissection, Aortic
TAA Thoracoabdominal Aortic Aneurysm
Thoracic Aortic Aneurysm
Transection Aorta
Keywords: TEVAR
Aneurysm
Dissection
Aorta
Endovascular stent graft
Thoracic branch endoprosthesis
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 200
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: Registry participants are derived from patients presenting with vascular disease that may benefit from the placement of an endovascular stent graft. The target registry population is patients who are treated with TBE at participating sites. Only patients who meet all the inclusion and none of the exclusion criteria will be included in the registry.

The registry has been designed with broad eligibility criteria to optimize the visibility of overall registry device use. An integral requirement to the target subject population is that the decision to use a TBE product has been made prior to considering the patient for possible registry participation. The TBE registry population will be defined as a successful recipient of TBE at the end of the index procedure.

Brief summary: The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.

Detailed description: The purpose of the GORE® TAG® Thoracic Branch Endoprosthesis Registry is to collect real-world data for this device. Due to the nature of the registry, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions.

Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.

Eligibility criteria: Inclusion Criteria:

Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements Patient has been or is intended to be treated with an eligible registry device Patient is age ≥ 18 years at time of informed consent signature.

Exclusion Criteria:

Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.

Patient with exclusion criteria required by local law. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

Primary outcomes:
measure: Deployment Technical Success
timeFrame: Time of Surgery
measure: Lesion-related Mortality
timeFrame: Day 30 through Year 2
measure: Lesion Rupture (treated area)
timeFrame: Time of Surgery through Year 2
measure: Lesion Enlargement (treated area)
timeFrame: Time of Surgery through Year 2
measure: Endoleaks (Type I-V)
timeFrame: Time of Surgery through Year 2
measure: Device Migration
timeFrame: Time of Surgery through Year 2
measure: Loss of Aortic / Branch Patency
timeFrame: Time of Surgery through Year 2
measure: Stroke
timeFrame: Time of Surgery through Year 2
measure: Paraplegia
timeFrame: Time of surgery through Day 30
measure: Paraparesis
timeFrame: Time of surgery through Day 30
measure: New Onset Renal Failure
timeFrame: Time of surgery through Day 30
measure: Renal Function Deterioration
timeFrame: Time of surgery through Year 2
measure: Device Integrity Events
timeFrame: Time of Surgery through Year 2
measure: Reintervention
timeFrame: Time of Surgery through Year 2
Secondary outcomes:
measure: Access-related Complications
timeFrame: Time of Surgery through Year 2
measure: Transient Ischemic Attack (TIA)
timeFrame: Time of Surgery through Year 2
measure: Life Threatening Bleed
timeFrame: Time of Surgery through Year 2
measure: Upper Extremity Ischemia
timeFrame: Time of Surgery through Year 2
measure: False Lumen Status - Treated Segment
timeFrame: Time of Surgery through Year 2
measure: False Lumen Status - Untreated Segment
timeFrame: Time of Surgery through Year 2
measure: False Lumen Perfusion
timeFrame: Time of Surgery through Year 2
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Copenhagen
country: Denmark
facility: Rigshospitalet University Hospital
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Muenster
country: Germany
facility: Universitätsklinikum Münster
city: Athens
country: Greece
facility: Evangelismos General Hospital
city: Athens
country: Greece
facility: Laiko General hospital of Athens
city: Bologna
country: Italy
facility: Policlinico di Sant'Orsola
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Padova
country: Italy
facility: AOU Padova
city: Selargius
country: Italy
facility: Azienda Ospedaliera "G. Brotzu"
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Malmö
country: Sweden
facility: Skane University Hospital
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: London
country: United Kingdom
facility: St Mary's Hospital
Study officials:
References: