Objective of the study is to evaluate the performance of the CERAB configuration using Bentley covered stents.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Technical success is defined as successful implantation of the CERAB device
without occlusion during the first 30-days after implantation and
without conversion to open repair
- Primary patency at 12 months
Secondary outcome
Technical:
* Patency rates
* Target vessel revascularization rate
* Conversion to open surgery
Clinical:
* Freedom from Reinterventions
* 30-day morbidity
* Incidence of serious adverse events device or procedural related within the
3, 6 and 12 months post intervention period
* Overall and reintervention-free survival
* Clinical improvement, as measured by the Rutherford category
*Patient reported outcomes including general health status, Quality of life and
disease specific outcomes
Background summary
Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive
disease (AOID), also in extensive pathology. This is related to its minimally
invasiveness, decreasing the procedural morbidity rate. When the aortic
bifurcation was involved in the lesion, the patency rates of kissing stents
configurations were often inferior to open repair. In 2013 the Covered
Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique was
introduced in an attempt to improve endovascular treatment results by a more
anatomical and physiological reconstruction, with a subsequent improved
clinical outcome.
Study objective
Objective of the study is to evaluate the performance of the CERAB
configuration using Bentley covered stents.
Study design
This is a real world, multicenter, prospective investigator initiated trial to
get a further insight on the efficacy of the CERAB procedure for extensive
aortoiliac occlusive disease.
Intervention
CERAB-technique, as described in the introduction of the study protocol.
Study burden and risks
Risk assessment can be found in chapter 14.1 of the study protocol.
Wagnerlaan 55
Arnhem 6800TA
NL
Wagnerlaan 55
Arnhem 6800TA
NL
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL65682.091.18 |