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| ID | Type | Description | Link |
|---|---|---|---|
| TGR 23-02TA | Other Identifier | WL Gore |
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An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w/AC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aneurysm/Other Isolated Lesion |
| ||
| Dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular | Device | TEVAR - thoracic endovascular aortic repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Deployment Technical Success |
| Index Procedure |
| Lesion-related Mortality | Death meeting at least one of the following characteristics:
| From time of index procedure through 10 years of follow-up |
| 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. | Through 10 years post-procedure |
| 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. | Through 10 years post-procedure |
| Endoleaks | Perfusion of a treated lesion via:
|
| Measure | Description | Time Frame |
|---|---|---|
| Access-related complications | Complications associated with the access sites used during treatment that may include pseudoaneurysm, hematoma, thrombosis, or complications associated with percutaneous closure devices. | Intra-operatively |
| Transient Ischemic Attack (TIA) |
| Measure | Description | Time Frame |
|---|---|---|
| Health Economic and Quality of Life Data Analysis | A Health Economic analysis is planned as part of the clinical registry. Initial analyses will only involve data that is collected within the registry CRFs. The objective of the Health Economic analysis is to understand the short- and long-term healthcare resource use and costs of the treatment(s) studied during the period of the clinical registry. Quality of life will also be evaluated at some sites within the Europe, Middle East and Africa (EMEA) regions and Asia-Pacific (APAC) regions, as applicable, using a standard survey. |
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 investigational drug and/or investigational device study* within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.
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The target registry population is patients who are treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL at participating sites. This includes initial procedures and reinterventions (regardless of original intervention).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Hoedt, MS | Contact | +1 928-864-3987 | ahoedt@wlgore.com |
| Name | Affiliation | Role |
|---|---|---|
| Ali Azizzadeh, M.D. | Cedars-Sinai Medical Center | Principal Investigator |
| Timothy Resch | Univ. of CPH - Denmark | Principal Investigator |
| Kazuo Shimamura |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Tucson | Arizona | 85724 | United States |
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| Through 10 years post-procedure |
| Device Migration | 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. | Through 10 years post-procedure |
| 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. | Through 10 years post-procedure |
| Stroke (All, Serious, Non-Serious) | 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:
| Through 10 years post-procedure |
| Paraplegia (within 30 days of index procedure) | New onset spinal cord injury rendering a subject non-ambulatory within 30 days of the index procedure | Within 30 days of index procedure |
| Paraparesis (within 30 days of index procedure) | New onset spinal cord injury causing a minor motor deficit of the lower extremities within 30 days of the index procedure | Within 30 days of index procedure |
| New onset renal failure (within 30 days of index procedure) | New onset sustained renal failure identified within 30 days of the index procedure, combined with requiring dialysis for > 4 weeks | Within 30 days of index procedure |
| Renal function deterioration | New onset of a decrease in eGFR > 30% following treatment when compared to baseline eGFR. | Within 30 days of index procedure |
| Device integrity events (e.g., fracture, kinking, compression) | Defined as any of the following:
| Through 10 years post-procedure |
| 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. | Through 10 years post-procedure |
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) |
| Through 10 years post-procedure |
| New Dissection | A new arterial tear either caused by a stent graft, natural disease progression or iatrogenic injury from endovascular manipulation. This can include the propagation, or extension, of a previous dissection that was not present at the time of initial presentation. | Through 10 years post-procedure |
| False Lumen Status - treated segment | Status of the false lumen within the segment of the aorta initially treated with an endovascular stent graft:
| Through 10 years post-procedure |
| False Lumen Status - untreated segment | Status of the false lumen outside of the segment of the aorta initially treated with an endovascular stent graft:
| Through 10 years post-procedure |
| False Lumen Perfusion | Flow into the false lumen via:
| Through 10 years post-procedure |
| Through 10 years post-procedure |
| Osaka University Hospital - Japan |
| Principal Investigator |
| University of Southern California | Recruiting | Los Angeles | California | 90033 | United States |
|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
|
| Leland Stanford Junior University | Recruiting | Stanford | California | 94305 | United States |
|
| MedStar Health, MedStar Washington Hospital Center | Not yet recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| University of Florida - Gainesville | Recruiting | Gainesville | Florida | 32610 | United States |
|
| University of South Florida | Recruiting | Tampa | Florida | 33606 | United States |
|
| Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
|
| Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| University of Maryland - Baltimore | Recruiting | Baltimore | Maryland | 21201 | United States |
|
| Beth Israel Deaconess Medical Center | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
|
| The Hitchcock Foundation at Dartmouth Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
|
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
|
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
|
| University Hospitals - Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| University of Pennsylvania | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Thomas Jefferson University | Not yet recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| Baylor Research Institute | Recruiting | Dallas | Texas | 75246 | United States |
|
| Columbia Medical Center of Plano | Recruiting | Plano | Texas | 75075 | United States |
|
| Intermountain Medical Center | Recruiting | Murray | Utah | 84157 | United States |
|
| Sentara Medical Group, Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23437 | United States |
|
| University of Washington | Not yet recruiting | Seattle | Washington | 98195 | United States |
|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53792 | United States |
|
| Rigshospitalet | Recruiting | Copenhagen | DK-2100 | Denmark |
|
| Centre Hospitalier Universitaire Strasbourg | Recruiting | Strasbourg | 67000 | France |
|
| Universitatsmedizin Frankfurt | Recruiting | Frankfurt | Germany |
|
| Regensburg University Hospital | Recruiting | Regensburg | D-93053 | Germany |
|
| Regensburg University Hospital | Recruiting | Regensburg | D-93053 | Germany |
|
| Universitatsklinikum Ulm | Recruiting | Ulm | D-89081 | Germany |
|
| Laiko General Hospital of Athens | Recruiting | Athens | 11527 | Greece |
|
| AORN S.Anna e S. Sebastiano | Recruiting | Caserta | Italy |
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| IRCCS Policlinico di Milano | Recruiting | Milan | Italy |
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| King Faisal Specialist Hospital and Research Center | Recruiting | Ryadh | Saudi Arabia |
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| Hospital Universitari de Bellvitge | Recruiting | Barcelona | 08907 | Spain |
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| Uppsala University | Recruiting | Uppsala | SE-751 85 | Sweden |
|
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D000784 | Aortic Dissection |
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D001014 | Aortic Aneurysm |
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