Aortic Arch Aneurysm, Chronic Aortic Dissection, Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Conditions
Keywords
Complex aortic repair, Aortic aneurysm, Aortic dissection, Fenestrated/branched endograft, Custom-made endovascular graft
Brief summary
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.
Interventions
PROCEDUREEndovascular Aortic Treatments
Use of Cook's custom-made endovascular grafts to treat complex abdominal, thoracoabdominal aortic diseases, or aortic arch diseases such as aneurysms and dissections.
Sponsors
Cook Research Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1\. Patients who will be treated with a Cook CMD
Exclusion criteria
1. Patients who declare they are unable to complete clinical follow-up visit at the time of enrollment, or 2. Patients or his/her legally authorized representative objects to extraction of patient's data from the medical record, or unwilling to sign the Informed Consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of treatment success | 12 months | 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. |
| Rate of safety outcomes | 30 days | 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) |
Countries
Denmark, France, Germany, Italy, Sweden, United Kingdom
Contacts
CONTACTGregoire Masliah
PRINCIPAL_INVESTIGATORStephan Haulon, MD,PhD
Hopital Marie Lannelongue
Outcome results
None listed