The Surpass intracranial aneurysm embolization system pivotal trial to treat large or giant wide neck aneurysms

The Surpass intracranial aneurysm embolization system pivotal trial to treat large or giant wide neck aneurysms - SCENT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39950

Enrollment

Registered

2013-01-25

Start date

2013-03-19

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

aneurysm bulge

Interventions

The device is called the Surpass Flow Diverter and is intended to treat large or giant wide neck intracranial aneurysms.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: age 19-80 years subject has a single targeted intracranial aneurysm that: - located in the internal carotid artery distribution up to the terminus -is able to cross with a standard 0,014"guide wire -has a neck > 4mm or no discernible neck and an aneurysm size > 10mm

Exclusion criteria

Exclusion criteria: - known allergy or contraindication to Aspirin, Clopidogrel/Plavix, heparin,local or general anesthesia. - known history of life threathening allergy to contrast dye - More than one intracranial aneurysm that requires treatment within 12 months - unstable neurological deficit - extra-cranial stenosis or parent vessel with stenosis > 50% in the area proximal to the aneurysm

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the percent of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis (defined as	—

Secondary

Measure	Time frame
The secondary safety endpoint is the percent of subjects experiencing one or more serious adverse events (SAE) through 12 months post-index procedure within the following categories (see definitions section of this protocol), as adjudicated by the Clinical Events Committee (CEC). • Proportion of subjects with new or worsening major ipsilateral stroke • Proportion of subjects experiencing acute or subacute (=50% stenosis of flow diverter) • Parent artery occlusion at the target aneurysm location (>=50% stenosis) • Functional status: change in the modified Rankin score compared to baseline • Technical success: defined as the proportion of subjects in whom the Surpass implant(s) was delivered to cover the aneurysm neck. • Proportion of subjects with Raymond Class 1, 2 and 3 at 6 months • Proportion of subjects with complete occlusion at 6 months • Incidence of retreatment (with Surpass System or otherwise) at 6, 12, 24 and up to 60 months • Surpass Flow Diverter success: implant successfully delivered to the target location	—

Measure

Time frame

The secondary safety endpoint is the percent of subjects experiencing one or more serious adverse events (SAE) through 12 months post-index procedure within the following categories (see definitions section of this protocol), as adjudicated by the Clinical Events Committee (CEC). • Proportion of subjects with new or worsening major ipsilateral stroke • Proportion of subjects experiencing acute or subacute (=50% stenosis of flow diverter) • Parent artery occlusion at the target aneurysm location (>=50% stenosis) • Functional status: change in the modified Rankin score compared to baseline • Technical success: defined as the proportion of subjects in whom the Surpass implant(s) was delivered to cover the aneurysm neck. • Proportion of subjects with Raymond Class 1, 2 and 3 at 6 months • Proportion of subjects with complete occlusion at 6 months • Incidence of retreatment (with Surpass System or otherwise) at 6, 12, 24 and up to 60 months • Surpass Flow Diverter success: implant successfully delivered to the target location

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)