Last reviewed · How we verify
NCT04034810: FIRST
Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment
trial testing Intracranial aneurysm treated with Silk vista and silk vista baby in Intracranial Aneurysm in 234 participants. Participants enrolled and being followed up; not accepting new ones.
1 March 2023
Quick facts
| Lead sponsor | Balt Extrusion |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 234 |
| Start date | 4 November 2019 |
| Primary completion | 1 March 2023 |
| Estimated completion | 30 November 2027 |
| Sites | 29 locations across France, Italy, Netherlands, Belgium, Austria, Germany, Israel, Croatia |
Drugs / interventions tested
- Intracranial aneurysm treated with Silk vista and silk vista baby
Conditions studied
- Intracranial Aneurysm — all drugs for Intracranial Aneurysm →
- Flow Diverter — all drugs for Flow Diverter →
Sponsor
Balt Extrusion
Who can join
18 and older, any sex, with Intracranial Aneurysm or Flow Diverter. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04034810
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Intracranial Aneurysm
Currently open trials in the same condition.
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- NCT06588543 — Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping · recruiting
- NCT05831202 — SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial · Phase 3 · active not recruiting
- NCT06416657 — General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Usin · NA · recruiting
Other Balt Extrusion trials
Trials by the same sponsor.
- NCT03642821 — Intracranial Aneurysms Treatment With the OPTIMA Coil System · completed
- NCT03504436 — Endovascular Treatment of Wide Neck Intracranial Aneurysms With the LEO + Stent : The LEO + II Cohort Study · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04034810 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Balt Extrusion
- Last refreshed: 17 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04034810.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing