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.
ID
Bron
Verkorte titel
Aandoening
Abdominal Aortic Aneurysm
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
None
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8044 |
| Ander register | METC Leiden-Den Haag-Delft : 18-128 |