Vascular DiseasesARCHIBALDNCT03269734
Evaluation of the Accuracy of the Vessel Navigator Tool for Catheterization of Supra-aortic Vessels - ARCHIBALD
An observational study of Vascular Diseases and Cerebrovascular Diseases, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
This study compares the accuracy of fusion imaging (Fusion Roadmap) versus real-time X-ray imaging (Roadmap) during catheterization of supra-aortic trunks of in patients with aneurysms or arteriovenous malformations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases, Cerebrovascular Diseases, Cardiovascular Diseases
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations, arterial cervical or intracranial stenosis, head and neck vascular tumors.
Who may be able to join
- Preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations, arterial cervical or intracranial stenosis, head and neck vascular tumors.
Who cannot join
- Patients with contraindication to intravenous contrast.
- Patients with catheterization of the supra-aortic vessels in an emergency settings (Stroke, acute bleeding)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Accuracy of the Vessel Navigator (Philips Healthcare) Tool for Catheterization of Aortic Arch and Supra-aortic Vessels - ARCHIBALD
This study compares the accuracy of fusion imaging (Fusion Roadmap) versus real-time X-ray imaging (Roadmap) during catheterization of supra-aortic trunks of in patients with aneurysms or arteriovenous malformations.
Read the detailed description
Catheterization of is performed for the diagnosis and treatment of cerebrovascular diseases. It is performed under X-ray scopy in frontal incidence with possible variations of the angulation of the arch to optimize the visualization of vessels 'origin (brachiocephalic trunk, left and right common carotid arteries, subclavian arteries).
Before the beginning of catheterization, a conventional arterial roadmap with iodine injection is usually performed. The Vessel Navigator (VN) developed by Philips allows the use of pre-acquired angio-scan or angio-MRI image by superimposing it (X-ray Fusion) on X-ray scopy to provide the arterial tracing (Fusion Roadmap).
An angio-MRI (Philips 3 Tesla MRI) imaging of the aortic arch will be first performed (as part of preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations). A first operator will perform the arteriography under the usual conditions without using the VN. A second operator will have access to the fusion imaging and will assess the accuracy of the coregistration. Snapshots will be taken by the second operator.
- Conditions
- Vascular Diseases, Cerebrovascular Diseases, Cardiovascular Diseases, Aortic Aneurysm, Arteriovenous Malformation
- Keywords
- Vascular Diseases, Cerebrovascular Diseases, Cardiovascular Diseases, Aortic aneurysm, Arteriovenous malformations, Catheterization
- Medical subject headings
- Vascular Diseases, Cerebrovascular Disorders, Cardiovascular Diseases, Aortic Aneurysm, Arteriovenous Malformations
What is being measured
The primary outcome is the main question the study is designed to answer.
Offset (in mm) between the lateral edge of the opacified artery and that visualized with the fusion imaging.
Measurement will be performed 1 cm above each ostium. There will be 4 measurements per patient (4 vessels analyzed).
Measured: baseline
Secondary outcomes (1)
Subjective opinion of the second operator on the aspect of registration to carry out the catheterization (satisfactory or not).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Dec 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Raphaël BLANC, MD, Principal investigator, Fondation ophtalmologique de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269734
- Sponsor's protocol ID
- NI_RBC_2016_1
- Acronym
- ARCHIBALD
- Status last verified
- Dec 2017
- First submitted
- 30 Aug 2017
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of the Vessel Navigator (Philips Healthcare) Tool for Catheterization of Aortic Arch and Supra-aortic Vessels - ARCHIBALD
- ClinicalTrials.gov ID
- NCT03269734
- Acronym / sponsor ID
- ARCHIBALD / NI_RBC_2016_1
- Conditions
- Vascular Diseases, Cerebrovascular Diseases, Cardiovascular Diseases, Aortic Aneurysm, Arteriovenous Malformation
- Keywords
- Vascular Diseases, Cerebrovascular Diseases, Cardiovascular Diseases, Aortic aneurysm, Arteriovenous malformations, Catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the accuracy of fusion imaging (Fusion Roadmap) versus real-time X-ray imaging (Roadmap) during catheterization of supra-aortic trunks of in patients with aneurysms or arteriovenous malformations.
Detailed description
Catheterization of is performed for the diagnosis and treatment of cerebrovascular diseases. It is performed under X-ray scopy in frontal incidence with possible variations of the angulation of the arch to optimize the visualization of vessels 'origin (brachiocephalic trunk, left and right common carotid arteries, subclavian arteries).
Before the beginning of catheterization, a conventional arterial roadmap with iodine injection is usually performed. The Vessel Navigator (VN) developed by Philips allows the use of pre-acquired angio-scan or angio-MRI image by superimposing it (X-ray Fusion) on X-ray scopy to provide the arterial tracing (Fusion Roadmap).
An angio-MRI (Philips 3 Tesla MRI) imaging of the aortic arch will be first performed (as part of preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations). A first operator will perform the arteriography under the usual conditions without using the VN. A second operator will have access to the fusion imaging and will assess the accuracy of the coregistration. Snapshots will be taken by the second operator.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations, arterial cervical or intracranial stenosis, head and neck vascular tumors.
Key inclusion criteria (1 listed)
- Preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations, arterial cervical or intracranial stenosis, head and neck vascular tumors.
Key exclusion criteria (2 listed)
- Patients with contraindication to intravenous contrast.
- Patients with catheterization of the supra-aortic vessels in an emergency settings (Stroke, acute bleeding)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Offset (in mm) between the lateral edge of the opacified artery and that visualized with the fusion imaging.
Time frame: baseline
Measurement will be performed 1 cm above each ostium. There will be 4 measurements per patient (4 vessels analyzed).
1 secondary outcome
Subjective opinion of the second operator on the aspect of registration to carry out the catheterization (satisfactory or not).
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphaël BLANC, MD principal investigator
Fondation ophtalmologique de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases and Cerebrovascular Diseases, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Offset (in mm) between the lateral edge of the opacified artery and that visualized with the fusion imaging. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.