Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities (SURF)

Penumbra

Status: Completed

Conditions: Aneurysm, Brain

Treatments: Device: WAVE, as part of the SMART COIL System

Study type: Observational

Funder types: Industry

Identifiers

NCT04106583

CLP 13669

Details and patient eligibility

About

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.

Enrollment: 572 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient age ≥ 18 years
• Patient having embolization of intracranial aneurysms
• WAVE Extra Soft Coil is final finishing coil
• Penumbra SMART COIL System accounts for at least 75% of total number of coils implanted
• Informed consent obtained per Institutional Review Board/Ethics Committee (IRB/EC) requirements

Exclusion criteria

• Life expectancy less than 1 year
• Patient previously enrolled in the SURF Study
• Known multiple intracranial aneurysms requiring treatment during index procedure
• Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
• Participation in an interventional drug or device study that may confound the results of the study

Trial design

572 participants in 1 patient group

Single Arm

Description:

Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System

Treatment:

Device: WAVE, as part of the SMART COIL System