No registrations found.
ID
Source
Brief title
Health condition
Abdominal Aortic Aneurysm
Sponsors and support
Intervention
Outcome measures
Primary outcome
The trial is designed with primary efficacy and primary safety endpoints.
The primary efficacy endpoint of the study is technical success defined by stentgraft deployment at the desired location without type I, III or IV endoleak and successful percutaneous access and closure at the end of the procedure.
The primary safety endpoint of the study is absence of type I, III or IV endoleak or device, and absence of access or procedure related major adverse events at one month.
Major adverse events are defined as any death, myocardial infarction, stroke, dialysis requiring renal failure or surgical conversion at the aneurysm or access sites.
Secondary outcome
Numbers of percutaneous closure device failure.
Numbers of surgical conversion at the access site.
Numbers of patients with local anesthesia, sedation and general anesthesia required for the implantation of the stentgraft.
Peri-procedural blood loss.
Number of ICU days.
Number of days hospital stay.
At one month and 12 months:
Surgical conversion at the aneurysm site
Surgical conversion at the access site
Pseudoaneurysms at the access site.
Distal emboli
Graft thrombosis
Graft fracture
Graft migration of 10 mm or more
Endoleaks type I, III & IV
Endoleaks type II
Secondary procedures to correct endoleaks
Secondary procedures to correct kinking or thrombosis of graft
Major amputation
All cause mortality
Aneurysm rupture related mortality
Graft related mortality
Myocardial infarction
Bowel ischemia
Stroke
Renal ischemia causing dialysis
Background summary
This study is a registry for the percutaneous use of the low profile Cordis Incraft endoprosthesis in combination with Proglide closing devices when treating abdominal aortic aneurysms.
Study objective
Although this is a registry, we think that the percutaneous use of low profile endoprostheses combined with closure devices will decrease morbidity and length of stay.
Study design
Regarding the fact that 10 centers will enroll 100 patients and that some centers will begin before or after others an enrollment period of two years is expected.
After the enrollment period one year is necessary for follow-up. In addition ½ year for final data collection.
Thus a total estimated study period of 3.5 years.
Intervention
None
Inclusion criteria
Age ≥ 18 years
Candidacy for endovascular repair of the aneurysm of the aorta (AAA)
AAA with the following criteria
≥55 mm in diameter or growth ≥5mm during 6 months
Or saccular AAA
Elective (Non-ruptured)
Femoral access to fit the delivery system
Exclusion criteria
Dissection of the infrarenal aorta
Ruptured aorta
Infrarenal aorta angulation ≥ 60 °
Aortic bifurcation ≤ 18mm in diameter
Aortic length ( from lowest renal artery to aortic bifurcation) < 8.7 cm
Circumferential thrombosis and/or calcification of infrarenal neck
GFR < 20
High probability of non-adherence to the study
Participation in concurrent aorto-iliac trial
Incapability of the patient
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8044 |
| Other | METC Leiden-Den Haag-Delft : 18-128 |