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Coil
Single Arm for Brain Aneurysm (SURF Trial)
N/A
Waitlist Available
Led By Clemens M Schirmer, MD
Research Sponsored by Penumbra Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Summary
The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities.
Eligible Conditions
- Brain Aneurysm
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy: Adequate Occlusion
Safety: Serious Adverse Events (SAEs)
Secondary outcome measures
Aneurysm
Efficacy: Aneurysm Recanalization or Progressive Thrombosis
Efficacy: Occlusion rate
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
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Who is running the clinical trial?
Penumbra Inc.Lead Sponsor
36 Previous Clinical Trials
9,035 Total Patients Enrolled
Clemens M Schirmer, MDPrincipal InvestigatorGeisinger Clinic
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