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The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.
Data will be collected both retrospectively and prospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gelsoft Plus - Straights and Bifurcated | Patients with aneurysmal or occlusive disease, including those with connective tissue disorders who have received/will receive a Gelsoft Plus Straight or Bifurcate, implanted in the abdomen or peripheral arteries in the last 5 years and from study launch onwards. |
| |
| Gelsoft Plus - Extra-Anatomical | Any patients who have received/will receive a Gelsoft Plus Extra-Anatomical supported or unsupported graft, implanted for: axillary-femoral bypass, femoral-femoral bypass or femoral-popliteal bypass in the last 5 years and from study launch onwards. |
| |
| Cardiovascular Patches - Gelseal, Gelsoft, Thin Wall | Patients who have been implanted with/require a cardiovascular patch for: thoracic vessel repair with a Gelseal Cardiovascular Patch; abdominal or peripheral vessel repair with a Gelsoft Cardiovascular Patch; or carotid endarterectomy with a Thin Wall Carotid Patch in the last 5 years and from study launch onwards. |
| |
| Gelweave - Abdominal, Thoracic, Thoracoabdominal | Patients who, due to either aneurysmal or occlusive disease, have had/require vascular repair of one of the following, implanted in the last 5 years and from study launch onwards:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gelsoft Plus Vascular Graft | Device | Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative Death | 30 Day or In-Hospital Mortality | 1 Year |
| Graft Leakage | Device Failure: The presence of leakage or excessive bleeding through graft/patch | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Device Endpoints | Device failures, requirement for reintervention or device related adverse events | 1 Year |
| Procedural Endpoints | Rifampicin or heparin soaking, procedure related adverse events |
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Inclusion Criteria:
All Patients:
Patient meets the minimum age as per local regulations at time of consent
Patient requires treatment with study device(s) according to the IFU(s)
Patient is willing and able to comply with all SOC procedures and study visits
Patient or their legally authorised representative (LAR) has given written informed consent to participate in study, including consent to collect data retrospectively
Retrospective Patients only:
Exclusion Criteria:
Any patient who meets any of the following exclusion criteria will be excluded from participation in the study:
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Patients who require treatment, or have already received treatment within the last 5 years, with the following commercially available Terumo Aortic knitted and woven grafts and cardiovascular patches:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Manager | Contact | +44 141 343 0194 | r.smith1@terumoaortic.com | |
| TA UK Clinical Research | Contact | +44 141 812 5555 | clinicalresearchuk@terumoaortic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz | Recruiting | Aurora | Colorado | 80045 | United States |
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|
| Gelweave - Valsalva | Patients who have had/require aortic root repair using valve sparing or valve replacing procedures, with or without replacement of the aortic arch, implanted in the last 5 years and from study launch onwards. |
|
|
| Vascular Bypass Graft | Device | Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels. |
|
|
| Cardiovascular Patch | Device | Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels. |
|
|
| Gelweave Vascular Graft | Device | The Gelweave woven polyester vascular graft allows replacement of large sections of arteries and, following anastomosis to the native blood vessel, provides a stable conduit for blood flow. |
|
|
| Gelweave Valsalva Vascular Graft | Device | This woven polyester graft is designed to match the aortic root anatomy and is implanted to repair or replace a portion of the aorta in case of an aneurysm, dissection or coarctation at the level of the thoracic aorta. |
|
|
| 1 Year |
| Safety Endpoints | Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke | 1 Year |
| University of South Florida - Tampa General | Recruiting | Tampa | Florida | 33620 | United States |
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| Indiana University Health | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
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| East Carolina University | Recruiting | Greenville | North Carolina | 27858 | United States |
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| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Lehigh Valley Hospital | Recruiting | Allentown | Pennsylvania | 18103 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19105 | United States |
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| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
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| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
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| AZ Groeninge Kortrijk | Recruiting | Kortrijk | 8500 | Belgium |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| Hamilton General | Not yet recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| CHU Bordeaux | Withdrawn | Bordeaux | France |
| CHU Clermont Ferrand | Recruiting | Clermont-Ferrand | France |
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| CHU de Dijon | Recruiting | Dijon | France |
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| CHU de Lille | Recruiting | Lille | 59000 | France |
|
| Hôpital Nord Marseille | Recruiting | Marseille | 13015 | France |
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| CHU de Rennes | Withdrawn | Rennes | 35033 | France |
| Hôpitaux Universitaires de Strasbourg - Hôpital Civil | Recruiting | Strasbourg | 67091 | France |
|
| CHU de Toulouse - Hôpital Rangueil | Recruiting | Toulouse | 31059 | France |
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| Charité Berlin | Recruiting | Berlin | 12200 | Germany |
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| Uniklinik Bonn | Recruiting | Bonn | 53127 | Germany |
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| UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen | Recruiting | Freiburg im Breisgau | Germany |
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| UKE Hamburg | Recruiting | Hamburg | 20251 | Germany |
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| Heart Center Leipzig | Recruiting | Leipzig | Germany |
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| Universitätsmedizin Mainz (University Hospital Mainz) | Recruiting | Mainz | 55131 | Germany |
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| Ludwig-Maximilian Universität (LMU) Klinikum | Recruiting | Munich | 81377 | Germany |
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| Semmelweis University Heart and Vascular Center | Completed | Budapest | Budapest | 1122 | Hungary |
| Amphia Hospital (Ziekenhuis) Breda | Recruiting | Breda | 4818 | Netherlands |
|
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D000094628 | Aortic Root Aneurysm |
| D000094630 | Dissection, Ascending Aorta |
| D020212 | Carotid Artery Injuries |
| D001018 | Aortic Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017545 | Aortic Aneurysm, Thoracic |
| D001014 | Aortic Aneurysm |
| D000094629 | Dissection, Thoracic Aorta |
| D000784 | Aortic Dissection |
| D000094665 | Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020214 | Cerebrovascular Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D058017 | Vascular Grafting |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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