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Completed

NCT Number: NCT04106583

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

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.

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Key information

Conditions

Aneurysm, Brain Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Foothills Medical Center, Calgary, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WAVE, as part of the SMART COIL System

Device

WAVE, as part of the SMART COIL System

Primary outcomes

  1. Efficacy: Adequate Occlusion

    Time frame: Through Study Completion, An Average of 1 Year

    Adequate occlusion defined as Raymond-Roy Class I and II at final follow-up

    Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.

  2. Safety: Serious Adverse Events (SAEs)

    Time frame: Up to 24 Hours Post-Procedure

    The primary safety endpoints are SAEs within 24 hours post-procedure

  3. Safety: Device-Related SAE

    Time frame: Through Discharge, up to 7 Days Post-Procedure

    Device-related SAE up to 7 days or discharge

Secondary outcomes

  1. Efficacy: Occlusion Rate

    Time frame: Immediate Post-Procedure

    Immediate post-procedure occlusion rates:

    Class 1 - Complete occlusion Class 2 - Residual neck Class 3 - Residual aneurysm

    The classification of angiographic results was adopted from Roy, Milot, and Raymond. Stroke 2001;32:1998-2004

  2. Efficacy: Retreatment Rate

    Time frame: Through Study Completion, An Average of 1 Year

    Retreatment rate at final follow-up

  3. Efficacy: Aneurysm Occlusion Raymond I

    Time frame: Immediate Post-Treatment

    Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.

  4. Efficacy: Aneurysm Occlusion Raymond I

    Time frame: Through Study Completion, An Average of 1 Year

    Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.

  5. Efficacy: Aneurysm Recanalization or Progressive Thrombosis

    Time frame: From Immediate Post Procedure Through Study Completion, An Average of 1 Year

    Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up

  6. Safety: Major Ipsilateral Stroke

    Time frame: Through Study Completion, An Average of 1 Year

    Occurrence of Major Ipsilateral Stroke

  7. Safety: Device-Related SAE

    Time frame: Through Study Completion, An Average of 1 Year

    Device related SAE at final follow-up

  8. Safety: Morbidity and Mortality

    Time frame: Through Study Completion, An Average of 1 Year

    All-cause morbidity and mortality at final follow-up

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Official study title

A Prospective, Multicenter Study Assessing the Embolization of Intracranial Aneurysms Using WAVE™ Extra Soft Coils, a Part of the Penumbra SMART COIL® System

Acronym: SURF

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2019
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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