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The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices.
The study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Aortic Treatments | Procedure | Use of Cook's custom-made endovascular grafts to treat complex abdominal, thoracoabdominal aortic diseases, or aortic arch diseases such as aneurysms and dissections. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of treatment success | Procedural treatment success is defined as successful access to the arterial system using remote arterial exposure, percutaneous technique or open surgical conduits. Success is also defined as successful delivery and deployment of the aortic graft and all stent components, side branch catheterization and placement of bridging stents and patency of all aortic modular stent graft components and intended side branch components. | 12 months |
| Rate of safety outcomes | Safety outcomes is defined as freedom from major adverse events (all-cause mortality, myocardial infarction, disabling stroke, renal failure requiring new-onset dialysis, respiratory failure requiring prolonged (>24hrs) mechanical ventilation or reintubation, paraplegia, bowel ischemia requiring surgical resection or not resolving with medical therapy) | 30 days |
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Inclusion Criteria:
1. Patients who will be treated with a Cook CMD
Exclusion Criteria:
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Patients receiving a Cook custom made endovascular graft within the scope of the study in a maximum of 20 clinical sites in Europe.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregoire Masliah | Contact | +41 795 490 954 | gregoire.masliah@cookmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Stephan Haulon, MD,PhD | Hopital Marie Lannelongue | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | Denmark | 8200 | Denmark | |
| Rigshospitalet |
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| Recruiting |
| Copenhagen |
| Denmark |
| 2100 |
| Denmark |
| Hopital Marie Lannelongue | Recruiting | Le Plessis-Robinson | 92350 | France |
| CHU de Lille | Recruiting | Lille | 59037 | France |
| University Hospital Hamburg Eppendorf | Recruiting | Hamburg | Germany | 20251 | Germany |
| LMU Klinikum Munich | Recruiting | Munich | Germany | 80337 | Germany |
| St. Franzikus-Hospital Munster | Recruiting | Münster | Germany | 48145 | Germany |
| Klinnikum Nurnberg | Recruiting | Nuremberg | Germany | 90471 | Germany |
| PoliclinicoS Orsola Malpighi | Recruiting | Bologna | 40138 | Italy |
| Orsola Maplighi | Recruiting | Bologna | Italy |
| Ospedal Policlinico San Martino-HSM | Recruiting | Genova | 16132 | Italy |
| IRCCS San Raffaele Hospital | Recruiting | Milan | 20132 | Italy |
| Skane University Hospital Malmo | Recruiting | Malmö | SE-205-02 | Sweden |
| Uppsala University Hospital | Recruiting | Uppsala | 75309 | Sweden |
| University Hospitals Birmingham NHS Foundation Trust | Recruiting | Birmingham | B9 5SS | United Kingdom |
| North Bristol NHS Trust | Recruiting | Bristol | BS10 5NB | United Kingdom |
| St Thomas' Hospital | Recruiting | London | SE1 9RT | United Kingdom |
| St Barthowlomew's | Recruiting | London | United Kingdom |
| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| D000094626 | Aneurysm, Aortic Arch |
| D001014 | Aortic Aneurysm |
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D017545 | Aortic Aneurysm, Thoracic |
| D000094665 | Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |
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