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Intracranial AneurysmFIRSTNCT04034810

Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment

An observational study of Intracranial Aneurysm and Flow Diverter, run by Balt Extrusion at 29 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The FIRST study is an observational, prospective, multi-center, international, single-arm, study. The aim of the study is to collect safety and efficacy information on the use of the silk vista and silk vista baby flow diverter in order to assess clinical safety and performance of the device for treating intracranial… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Aneurysm, Flow Diverter
What is being tested?
Intracranial aneurysm treated with Silk vista and silk vista baby
Type of treatment
Medical device
How many people
234 participants
Where
29 sitesin 9 countries
Study dates
4 Nov 2019to 30 Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 an intracranial aneurysm treated with silk vista and silk vista baby.

Who may be able to join

  • Patient with intracranial aneurysms intended to be treated with the silk vista and silk vista baby (decision of use silk vista and silk vista baby is done independently and prior to the participation of the patient in the study)
  • Patients with recanalized aneurysms previously treated with coils exclusively are also eligible.
  • In case of multiple aneurysms, only treatment with silk vista and silk vista baby are allowed (between the initial index procedure to the 12 months follow up visit)
  • Patient ≥ 18 years, who signed an informed consent.

Who cannot join

  • Patient presenting with contra-indications to the use of silk vista and silk vista babyaccording to the IFU (Instruction for Use).
  • Recanalized aneurysms initially treated with stent (including stent assisted coiling)

Trial locations and contacts

29 sites in 9 countries.

29 sites in 9 countries

France13 sites

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33000

  • Hopital Cavale Blanche

    Brest, 29200

  • Hospices Civils de Lyon - Hôpital Neurologique

    Bron, 69677

  • CHU Caen, Radiologie interventionelle

    Caen, 14033

  • Centre Hospitalier Universitaire Clermont Ferrand

    Clermont-Ferrand, 63003

  • Centre Hospitalier Universitaire de Grenoble Alpes

    Grenoble, 38043

  • Hôpital Kremlin Bicêtre

    Le Kremlin-Bicêtre, 94270

  • Chu Dupuytren Limoges

    Limoges, 87000

  • Hôpital Privé Clairval

    Marseille, 13009

  • Fondation Rothschild

    Paris, 75019

  • Pitié-Salpêtrière Hospital

    Paris, 75651

  • CHU Chalre Nicolle

    Rouen, 76000

  • Centre Hospitalier Régional Universitaire de Tours

    Tours, 37044

Other trials in France

Spain5 sites

  • Hospital Universitario de cruces

    Barakaldo, 48903

  • Ramon y Cajal hospital

    Madrid, 28034

  • Hopsital universidad puerta de hierro

    Madrid, 28222

  • Unversitario Central de Asturias

    Oviedo, 33011

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003

Other trials in Spain

Italy4 sites

  • Niguarda Hospital

    Milan, 20162

  • San Gerardo Hospital

    Monza, 20900

  • Cà Foncello Hospital

    Treviso, 31100

  • Santa maria della misericordia hospital

    Udine, 33100

Other trials in Italy

Israel2 sites

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Galilee Medical Center

    Nahariya, 22100

Other trials in Israel

Austria1 site

  • Universitätsklinik für Neurologie

    Salzburg, A-5020

Other trials in Austria

Belgium1 site

  • CHC Saint Joseph Liège

    Liège, 4000

Other trials in Belgium

Croatia1 site

  • University Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Germany1 site

  • Munich LMU University

    München, 81377

Other trials in Germany

Netherlands1 site

  • Radboud University medical Center

    Nijmegen, 6525 G

Other trials in Netherlands

About this study

Official title: Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment, an Observational, Prospective, Single Arm, International, Multicenter Study.

The FIRST study is an observational, prospective, multi-center, international, single-arm, study. The aim of the study is to collect safety and efficacy information on the use of the silk vista and silk vista baby flow diverter in order to assess clinical safety and performance of the device for treating intracranial aneurysms.

All patients with intracranial aneurysm ruptured or unruptured, whatever the localization of the aneurysm, and treated with silk vista or silk vista baby, will be consecutively enrolled in the study.

The patient's inclusion and follow up in the study will occur as part of their usual standard of care.

Being tested
Intracranial aneurysm treated with Silk vista and silk vista baby
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intracranial aneurysm treated with Silk vista and silk vista babyDevice

    Patients with intracranial aneurysm(s) intended to be treated with the silk vista and silk vista baby according to standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.

    Characterized by the rate of the permanent neurologic deficits and procedure related mortality.

    Measured: At 12-months (-3 / + 6 months) post procedure

  2. Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.

    Characterized by the clinical outcome assessed by mRS of the permanent neurologic deficits and procedure related mortality.

    Measured: At 12-months (-3 / + 6 months) post procedure

Secondary outcomes (15)

  1. Safety of silk vista and silk vista baby

    Assessed by the rate of adverse events

    Measured: At T0

  2. Safety of silk vista and silk vista baby

    Assessed by the rate of adverse events

    Measured: At hospital discharge

  3. Safety of silk vista and silk vista baby

    Assessed by the rate of adverse events

    Measured: Up to 30 days (-10 / + 21 days) post- procedure.

  4. Safety of silk vista and silk vista baby

    Assessed by the rate of adverse events

    Measured: At 6 months (-2/+3 months) post- procedure.

  5. Safety of silk vista and silk vista baby

    Assessed by the rate of adverse events

    Measured: At 12 months (-3/+6 months) post- procedure.

  6. Safety of silk vista and silk vista baby

    Assessed by the rate of adverse events

    Measured: At 3 years post procedure

  7. Safety of silk vista and silk vista baby

    Assessed by the rate of adverse events

    Measured: At 5 years post procedure

  8. Efficacy of silk vista and silk vista baby

    Assessed by aneurysm occlusion rate

    Measured: At T0

  9. Efficacy of silk vista and silk vista baby

    Assessed by aneurysm occlusion rate

    Measured: At hospital discharge

  10. Efficacy of silk vista and silk vista baby

    Assessed by aneurysm occlusion rate

    Measured: Up to 30 days (-10 / + 21 days) post- procedure.

  11. Efficacy of silk vista and silk vista baby

    Assessed by aneurysm occlusion rate

    Measured: Up to 6 months (-2/+3 months) post- procedure

  12. Efficacy of silk vista and silk vista baby

    Assessed by aneurysm occlusion rate

    Measured: Up to 12 months (-3 / + 6 months) post procedure

  13. Efficacy of silk vista and silk vista baby

    Assessed by aneurysm occlusion rate

    Measured: Up to 3 years post procedure

  14. Efficacy of silk vista and silk vista baby

    Assessed by aneurysm occlusion rate

    Measured: Up to 5 years post procedure

  15. Technical procedure

    The practices related to the use of silk vista baby will be describe

    Measured: At T0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2019
  2. Study start4 Nov 2019
  3. Primary completion1 Mar 2023
  4. Study completion30 Nov 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04034810
Sponsor's protocol ID
CIP 201802 SILK VISTA
Acronym
FIRST
Status last verified
Sep 2025
First submitted
23 Jul 2019
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm and Flow Diverter, run by Balt Extrusion at 29 sites in 9 countries.

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 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in France, Spain, Italy, Israel, Austria and 4 more countries. 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?

This study is still under way. Results are not available in the source record yet.

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?

Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms. (time frame: At 12-months (-3 / + 6 months) post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04034810.

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 29 Sep 2026.

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