Time Resolved Angiography in Cerebrovascular Shunts (TRACS)

Time Resolved Angiography in Cerebrovascular Shunts (TRACS) - TRACS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39157

Enrollment

200

Registered

2010-04-22

Start date

2010-07-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous malformations and dural arteriovenous fistulas

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient age 18 years or older Clinical suspicion of AVM or DAVF Diagnostic catheter angiography requested by treating physician

Exclusion criteria

Exclusion criteria: Absence of informed consent Diabetes mellitus Chronic kidney disease (baseline eGFR

Design outcomes

Primary

Measure	Time frame
With regard to each AVM or DAVF characteristic the sensitivity, specificity, positive and negative predictive power of 4D-CTA will be calculated when compared to the gold standard (CA). Also, the ability of 4D-CTA to correctly classify the lesion and to determine an appropriate treatment strategy will be compared to CA. Lesion analysis All CA and 4D-CTA images will be reviewed by two neuro-interventionalists and a neurosurgeon experienced in such evaluations. These reviewers will be blind for patient identity and the findings from the other imaging modality. The reviewers will assess the presence or absence of an AVM or DAVF, it*s classification and a number of clinically relevant characteristics based on a predefined score sheet. Treatment strategy For all patients, the reviewers will be asked to determine a treatment strategy based on the CA and 4D-CTA images, respectively. In addition, the reviewers will rate their degree of confidence concerning the chosen strategy based on a 5-point Likert scale (absolutely certain, sufficiently certain, ambiguous, insufficiently certain, absolutely uncertain). After reviewing the 4D-CTA images, each reviewer will be asked to address whether additional CA is expected to be of additional value.	—

Measure

Time frame

With regard to each AVM or DAVF characteristic the sensitivity, specificity, positive and negative predictive power of 4D-CTA will be calculated when compared to the gold standard (CA). Also, the ability of 4D-CTA to correctly classify the lesion and to determine an appropriate treatment strategy will be compared to CA. Lesion analysis All CA and 4D-CTA images will be reviewed by two neuro-interventionalists and a neurosurgeon experienced in such evaluations. These reviewers will be blind for patient identity and the findings from the other imaging modality. The reviewers will assess the presence or absence of an AVM or DAVF, it*s classification and a number of clinically relevant characteristics based on a predefined score sheet. Treatment strategy For all patients, the reviewers will be asked to determine a treatment strategy based on the CA and 4D-CTA images, respectively. In addition, the reviewers will rate their degree of confidence concerning the chosen strategy based on a 5-point Likert scale (absolutely certain, sufficiently certain, ambiguous, insufficiently certain, absolutely uncertain). After reviewing the 4D-CTA images, each reviewer will be asked to address whether additional CA is expected to be of additional value.

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Countries

Netherlands

Outcome results