Covered endovascular reconstruction of aortic bifurcation (CERAB) for extensive aortoiliac occlusive disease

Completed

Conditions: Narrowing vascular disease
10003216

Registration Number: NL-OMON48644

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

- Age 18 years or older
- Provided written informed consent
- Clinical necessity for treatment
- Eligible anatomy for CERAB without the need for chimney*s
- TASC-2 classification as assigned in the study protocol

Exclusion Criteria

- Patient is participating in another conflicting clinical study
- Patient*s life expectancy <2 years as judged by the investigator
- Patient has a psychiatric or other condition that may interfere with the study
- Patient has a known allergy to any device component
- Patients with a systemic infection who may be at increased risk of
endovascular graft infection.
- Patient has a coagulopathy or uncontrolled bleeding disorder
- Patient had a CVA or an MI within the prior three months
- Patient is pregnant (Female patients of childbearing potential only)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Technical success is defined as successful implantation of the CERAB device<br /><br>without occlusion during the first 30-days after implantation and<br /><br>without conversion to open repair<br /><br>- Primary patency at 12 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Technical:<br /><br>* Patency rates<br /><br>* Target vessel revascularization rate<br /><br>* Conversion to open surgery<br /><br><br /><br>Clinical:<br /><br>* Freedom from Reinterventions<br /><br>* 30-day morbidity<br /><br>* Incidence of serious adverse events device or procedural related within the<br /><br>3, 6 and 12 months post intervention period<br /><br>* Overall and reintervention-free survival<br /><br>* Clinical improvement, as measured by the Rutherford category<br /><br>*Patient reported outcomes including general health status, Quality of life and<br /><br>disease specific outcomes</p><br>