Clinical trial NCT04034810: Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment
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.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Aneurysm
Lead sponsor: Balt Extrusion
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an intracranial aneurysm treated with silk vista and silk vista baby.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. 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)
2. Patients with recanalized aneurysms previously treated with coils exclusively are also eligible.
3. 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)
4. Patient ≥ 18 years, who signed an informed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.
timeFrame: At 12-months (-3 / + 6 months) post procedure
measure: Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.
timeFrame: At 12-months (-3 / + 6 months) post procedure
Secondary outcomes:
measure: Safety of silk vista and silk vista baby
timeFrame: At T0
measure: Safety of silk vista and silk vista baby
timeFrame: At hospital discharge
measure: Safety of silk vista and silk vista baby
timeFrame: Up to 30 days (-10 / + 21 days) post- procedure.
measure: Safety of silk vista and silk vista baby
timeFrame: At 6 months (-2/+3 months) post- procedure.
measure: Safety of silk vista and silk vista baby
timeFrame: At 12 months (-3/+6 months) post- procedure.
measure: Safety of silk vista and silk vista baby
timeFrame: At 3 years post procedure
measure: Safety of silk vista and silk vista baby
timeFrame: At 5 years post procedure
measure: Efficacy of silk vista and silk vista baby
timeFrame: At T0
measure: Efficacy of silk vista and silk vista baby
timeFrame: At hospital discharge
measure: Efficacy of silk vista and silk vista baby
timeFrame: Up to 30 days (-10 / + 21 days) post- procedure.
measure: Efficacy of silk vista and silk vista baby
timeFrame: Up to 6 months (-2/+3 months) post- procedure
measure: Efficacy of silk vista and silk vista baby
timeFrame: Up to 12 months (-3 / + 6 months) post procedure
measure: Efficacy of silk vista and silk vista baby
timeFrame: Up to 3 years post procedure
measure: Efficacy of silk vista and silk vista baby
timeFrame: Up to 5 years post procedure
measure: Technical procedure
timeFrame: At T0
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Universitätsklinik für Neurologie
city: Liège
country: Belgium
facility: CHC Saint Joseph Liège
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
city: Brest
country: France
facility: Hopital Cavale Blanche
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Neurologique
city: Caen
country: France
facility: CHU Caen, Radiologie interventionelle
city: Clermont Ferrand
country: France
facility: Centre Hospitalier Universitaire Clermont Ferrand
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble Alpes
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Kremlin Bicêtre
city: Limoges
country: France
facility: Chu Dupuytren Limoges
city: Marseille
country: France
facility: Hôpital Privé Clairval
city: Paris
country: France
facility: Fondation Rothschild
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital
city: Rouen
country: France
facility: CHU Chalre Nicolle
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire de Tours
city: München
country: Germany
facility: Munich LMU University
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Milan
country: Italy
facility: Niguarda Hospital
city: Monza
country: Italy
facility: San Gerardo Hospital
city: Treviso
country: Italy
facility: Cà Foncello Hospital
city: Udine
country: Italy
facility: Santa maria della misericordia hospital
city: Nijmegen
country: Netherlands
facility: Radboud University medical Center
city: Baracaldo
country: Spain
facility: Hospital Universitario de cruces
city: Madrid
country: Spain
facility: Ramon y Cajal hospital
city: Madrid
country: Spain
facility: Hopsital universidad puerta de hierro
city: Oviedo
country: Spain
facility: Unversitario Central de Asturias
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
Study officials:
affiliation: Hospital Clinico Universitario de Valladolid (HCUV), Spain
name: Mario Martinez Galdamez, Dr
role: PRINCIPAL_INVESTIGATOR
References: