To set up a prospective cohort that facilitates evaluation of elective neurovascular treatments and that will serve as a multi-trial platform.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical parameters (e.g. co-morbidity, neurological history, symptoms, imaging
parameters, technical and treatment data), clinical endpoints (complication
rate, effectiveness, recurrence, technical outcome parameters, survival), and
patient reported outcomes (e.g. QOL).
Secondary outcome
N/A
Background summary
Approximately 3% of the general population harbors a neurovascular anomaly,
such as an aneurysm, arteriovenous malformation or dural arteriovenous fistula.
These conditions can cause debilitating symptoms, and sometimes carry a high
rupture risk which could lead to subarachnoid hemorrhage, a condition with poor
prognosis. Therefore, selected cases are treated preventively. The field of
neuro-interventional radiology has gained an important role in treatment of
neurovascular disease over the past decades next to the conventional
neurosurgical approach. Employing a minimally invasive approach through the
blood vessels, the techniques used within this field put a lower burden on the
patient compared to surgical approaches. At the same time, the neurosurgical
approach remains indispensible for more complicated cases. New devices are
developed at high pace, and being implemented in clinical practice without
evidence for their efficacy from randomized trials. Moreover, But long-term
efficacy data and long-term impact on quality of life often remain unknown. We
aim to build a neuro-interventional cohort according to the which will serve as
a multi-trial facility for interventional treatment studies. The Trials within
Cohorts (TwiCs) design, also known as cohort multiple Randomized Controlled
Trial design (cmRCT). This will be used both as a prospective registry for
assessment of long-term safety, performance and efficacy of innovative
neurovascular treatments, and as a multi trial facility for neurovascular
treatment studies. In this way, we can compare outcomes of different types of
neurovascular treatments and personalize them for future patients.
Study objective
To set up a prospective cohort that facilitates evaluation of elective
neurovascular treatments and that will serve as a multi-trial platform.
Study design
Observational, prospective cohort study, according to the *Trials within
Cohorts* (TwiCs) design.
Study burden and risks
No risk expected for patients participating in the study. Filling out the
questionnaires is the only burden for the patients participating in this
cohort. It will take approximately 15 minutes to fill out the questionnaires
each time.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Age >= 16 years.
- Patients with an intracranial aneurysm, arteriovenous malformation, or dural
arteriovenous fistula, referred for elective treatment at the UMC Utrecht.
- Informed consent - at least - for use of routinely collected clinical data.
Exclusion criteria
Mentally incompetent patients
Design
Recruitment
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 | NL78362.041.21 |