PANTHER: A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: Gelsoft Plus Vascular Graft
Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
Other Names:
|
| 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. |
Device: Vascular Bypass Graft
Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.
Other Names:
|
| 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. |
Device: Cardiovascular Patch
Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
Other Names:
|
| 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: Abdominal aorta, arteries arising from the abdominal aorta or peripheral arteries including femoral, iliac and popliteal arteries. Thoracic aorta or arteries arising from the thoracic aorta. Abdominal and thoracic aorta requiring a thoracoabdominal repair |
Device: Gelweave Vascular Graft
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.
Other Names:
|
| 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. |
Device: Gelweave Valsalva Vascular Graft
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Operative Death [1 Year]
30 Day or In-Hospital Mortality
- Graft Leakage [1 Year]
Device Failure: The presence of leakage or excessive bleeding through graft/patch
Secondary Outcome Measures
- Device Endpoints [1 Year]
Device failures, requirement for reintervention or device related adverse events
- Procedural Endpoints [1 Year]
Rifampicin or heparin soaking, procedure related adverse events
- Safety Endpoints [1 Year]
Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study:
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
-
For prospective emergency patients, retrospective consent is permissible
-
For retrospective patients who are deceased at time of enrollment, local EC regulations relating to consent process should be followed.
Retrospective Patients only:
-
Patient has a minimum of 1 year post-operative follow-up data available, or complete data to death.
-
Patient implant date is no more than 5 years prior to study start date.
Exclusion Criteria:
-
Any patient who meets any of the following exclusion criteria will be excluded from participation in the study:
-
Patient is unable or unwilling to comply with the SOC procedures or follow-up regime
-
Patient is contraindicated per the device IFU
-
Patient has any other 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Anschutz | Aurora | Colorado | United States | 80045 |
| 2 | University of South Florida - Tampa General | Tampa | Florida | United States | 33620 |
| 3 | Indiana University Health | Indianapolis | Indiana | United States | 46202 |
| 4 | Duke University | Durham | North Carolina | United States | 27705 |
| 5 | East Carolina University | Greenville | North Carolina | United States | 27858 |
| 6 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
| 7 | Ohio State University | Columbus | Ohio | United States | 43210 |
| 8 | Lehigh Valley Hospital | Allentown | Pennsylvania | United States | 18103 |
| 9 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19105 |
| 10 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
| 11 | UZ Gent | Gent | Belgium | 9000 | |
| 12 | AZ Groeninge Kortrijk | Kortrijk | Belgium | 8500 | |
| 13 | UZ Leuven | Leuven | Belgium | 3000 | |
| 14 | Hamilton General | Hamilton | Ontario | Canada | L8L 2X2 |
| 15 | CHU Bordeaux | Bordeaux | France | ||
| 16 | CHU Clermont Ferrand | Clermont-Ferrand | France | ||
| 17 | CHU de Dijon | Dijon | France | ||
| 18 | CHU de Lille | Lille | France | 59000 | |
| 19 | Hôpital Nord Marseille | Marseille | France | 13015 | |
| 20 | CHU de Rennes | Rennes | France | 35033 | |
| 21 | Hôpitaux Universitaires de Strasbourg - Hôpital Civil | Strasbourg | France | 67091 | |
| 22 | CHU de Toulouse - Hôpital Rangueil | Toulouse | France | 31059 | |
| 23 | Charité Berlin | Berlin | Germany | 12200 | |
| 24 | Uniklinik Bonn | Bonn | Germany | 53127 | |
| 25 | UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen | Freiburg | Germany | ||
| 26 | UKE Hamburg | Hamburg | Germany | 20251 | |
| 27 | Heart Center Leipzig | Leipzig | Germany | ||
| 28 | Universitätsmedizin Mainz (University Hospital Mainz) | Mainz | Germany | 55131 | |
| 29 | Ludwig-Maximilian Universität (LMU) Klinikum | Munich | Germany | 81377 | |
| 30 | Semmelweis University Heart and Vascular Center | Budapest | Hungary | 1122 | |
| 31 | Amphia Hospital (Ziekenhuis) Breda | Breda | Netherlands | 4818 |
Sponsors and Collaborators
- Vascutek Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PANTHER-001