Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE® TAG® Thoracic Branch Endoprosthesis | Patients treated with the TBE Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® TAG® Thoracic Branch Endoprosthesis | Device | Patients presenting with thoracic vascular disease that may benefit from the placement of TBE device. The target registry population is patients who are treated with TBE at participating sites. TBE treatment is qualified as receiving the TBE aortic component, at a minimum. |
| Measure | Description | Time Frame |
|---|---|---|
| Deployment Technical Success | Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system. The absence of any additional corrective procedure related to the device, procedure, or withdrawal of the delivery system. Events will not include interventions at the access site(s), lumbar drains to address spinal cord ischemia, or additional interventions to address non-treatment areas. | Time of Surgery |
| Lesion-related Mortality | Death related to the index endovascular procedure or following conversion to open repair and death related to a complication from a secondary procedure associated with the index lesion or registry device. Any death where the treated disease / index lesion or registry device caused or significantly contributed to the death, including lesion-rupture, aortic-related complications, disease progression involving the index lesion. | Day 30 through Year 2 |
| Lesion Rupture (treated area) | Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan. | Time of Surgery through Year 2 |
| Lesion Enlargement (treated area) | An increase in maximum vessel (e.g., aorta or treated branch) diameter of > 5 mm in the region encompassed by the initial lesion as compared to baseline using orthogonal (i.e., perpendicular to the centerline) measurements on CT / CTA scans. | Time of Surgery through Year 2 |
| Endoleaks (Type I-V) | Perfusion of a treated lesion identified through imaging analysis. | Time of Surgery through Year 2 |
| Device Migration |
| Measure | Description | Time Frame |
|---|---|---|
| Access-related Complications | Complications associated with the access sites used during treatment and any subsequent unplanned access-related reinterventions. This may include pseudoaneurysm, hematoma, thrombosis, or complications associated with percutaneous closure devices. | Time of Surgery through Year 2 |
Not provided
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.
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Wien | Vienna | A-1090 | Austria | |||
| Rigshospitalet University Hospital |
Data to be shared will be pseudo-anonymized with subject names and birthdates removed.
Not provided
Sharing of IPD will not routinely be performed and is contingent on an assessment of the researcher's proposal for novelty or value in advancing educational, quality or medical practice objectives in use of this data.
See above
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Longitudinal movement of all or part of the device for a distance ≥ 10 mm, as confirmed by CTA scan, relative to anatomical landmarks and device positioning at the first post-operative CTA scan. |
| Time of Surgery through Year 2 |
| Loss of Aortic / Branch Patency | No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation. | Time of Surgery through Year 2 |
| Stroke | Stroke is the acute onset of symptoms consistent with focal or multifocal central nervous system (CNS) injury caused by vascular blockage resulting in ischemia or vascular rupture resulting in hemorrhage, that either persists for > 24 hours or until death or symptoms lasting < 24 hours, with pathology or neuroimaging confirmation of CNS infarction. | Time of Surgery through Year 2 |
| Paraplegia | New onset spinal cord injury rendering a subject non-ambulatory. | Time of surgery through Day 30 |
| Paraparesis | New onset spinal cord injury causing a minor motor deficit of the lower extremities. | Time of surgery through Day 30 |
| New Onset Renal Failure | New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for > 4 weeks. | Time of surgery through Day 30 |
| Renal Function Deterioration | New onset of a decrease in eGFR > 30% following treatment when compared to baseline eGFR. | Time of surgery through Year 2 |
| Device Integrity Events | wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis. | Time of Surgery through Year 2 |
| Reintervention | Additional surgical or interventional procedure related to the treated disease / index lesion, the registry device, or to the treatment / procedure. This may include surgical or interventional treatment for endoleaks, access site(s) complications, disease progression (including interventions to address issues related to non-treated area of the index lesion, such as bare stent implantation to address bowel ischemia associated with aortic dissection), spinal drains for Spinal Cord Injury (SCI) management, or conversion to open surgery. | Time of Surgery through Year 2 |
| Transient Ischemic Attack (TIA) |
Transient focal neurological signs or symptoms (lasting <24 h) presumed to be due to focal brain ischemia but without evidence of acute infarction by neuroimaging or pathology (or in the absence of imaging) |
| Time of Surgery through Year 2 |
| Life Threatening Bleed | An event leading to either diagnosed hypovolemic shock, required four or more packed red blood cell units or directly led to subject death. | Time of Surgery through Year 2 |
| Upper Extremity Ischemia | Clinically-reported, device-related ischemia not evident at the time of the index procedure with CTA-verified branch vessel compromise (i.e., malperfusion) | Time of Surgery through Year 2 |
| False Lumen Status - Treated Segment | Status of the false lumen within the segment of the aorta initially treated with an endovascular stent graft. It is divided in patent, partial thrombosis and complete thrombosis. | Time of Surgery through Year 2 |
| False Lumen Status - Untreated Segment | Status of the false lumen outside of the segment of the aorta initially treated with an endovascular stent graft. It is divided in patent, partial thrombosis and complete thrombosis. | Time of Surgery through Year 2 |
| False Lumen Perfusion | Flow into the false lumen via Type IA entry flow, Type IB entry flow, Type II entry flow and Type R entry flow. | Time of Surgery through Year 2 |
| Copenhagen |
| 2100 |
| Denmark |
| Klinik für Gefäßmedizin, Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| University of Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Evangelismos General Hospital | Athens | 106 76 | Greece |
| Laiko General hospital of Athens | Athens | 11527 | Greece |
| Policlinico di Sant'Orsola | Bologna | 40138 | Italy |
| ASST Spedali Civili di Brescia | Brescia | 25123 | Italy |
| IRCCS Ospedale Policlinico San Martino | Genova | 16132 | Italy |
| AOU Padova | Padova | 35128 | Italy |
| Amsterdam UMC | Amsterdam | 1105 AZ | Netherlands |
| Radboud UMC | Nijmegen | 6525 GA | Netherlands |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Skane University Hospital | Malmö | 205 02 | Sweden |
| St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| St Mary's Hospital | London | W2 1NY | United Kingdom |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D000784 | Aortic Dissection |
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094665 | Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
Not provided
Not provided