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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aneurysm, Brain
• Intervention / Treatment: Device: WAVE, as part of the SMART COIL System

• Study Type: Observational
• Enrollment (Actual): 575

Contacts and Locations

Study Locations

• Canada
  • Calgary, Canada, T2N 2T9
    • Foothills Medical Center
  • Toronto, Canada, M5T 2S8
    • University Health Network
• Germany
  • Bremen, Germany
    • Bremen-Mitte
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Lübeck, Germany, 23538
    • UKSH - Campus Lübeck
• Italy
  • Novara, Italy
    • Maggiore della Carità
• Spain
  • Barcelona, Spain
    • Vall d'Hebron
  • San Sebastián, Spain
    • Donostia
• Switzerland
  • Basel, Switzerland
    • Universitatsspital Basel
• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Southeast Health Medical Center
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Banner UMC Tucson
  • California
    • La Mesa, California, United States, 91942
      • Sharp Grossmont
    • Thousand Oaks, California, United States, 91360
      • Los Robles
  • Colorado
    • Englewood, Colorado, United States, 80113
      • HRI - Swedish
    • Lakewood, Colorado, United States, 80228
      • St. Anthony's Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06320
      • Yale New Haven
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami (Jackson Memorial)
    • Tampa, Florida, United States, 33606
      • University of South Florida
    • Tampa, Florida, United States, 33756
      • Morton Plant
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Joliet, Illinois, United States, 60435
      • AMITA Health
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Metro Health
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • SSM Health Care
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Vidant Medical Center
  • Ohio
    • Toledo, Ohio, United States, 43608
      • Mercy St. Vincent
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • UPenn
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC
    • Greenville, South Carolina, United States, 29605
      • Greenville Memorial Hospital
  • Tennessee
    • Knoxville, Tennessee, United States, 37996
      • University of Tennessee Medical Center, Knoxville
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • McAllen, Texas, United States, 78503
      • McAllen Medical Center
    • Plano, Texas, United States, 75075
      • Texas Stroke Institute - DFW
  • Virginia
    • Newport News, Virginia, United States, 23601
      • Riverside Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Arm; Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System	Device: WAVE, as part of the SMART COIL System; WAVE, as part of the SMART COIL System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Adequate Occlusion	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.	Through Study Completion, An Average of 1 Year
Safety: Serious Adverse Events (SAEs)	SAEs within 24 hours post-procedure	Up to 24 Hours Post-Procedure
Safety: Device-Related SAE	Device-related SAE up to 7 days or discharge	Through Discharge, up to 7 Days Post-Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Occlusion rate	Immediate post-procedure occlusion rates	Immediate Post-Procedure
Efficacy: Retreatment Rate	Retreatment rate at final follow-up	Through Study Completion, An Average of 1 Year
Efficacy: Aneurysm Occlusion Raymond I	Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.	Immediate Post-Treatment
Efficacy: Aneurysm Occlusion Raymond I	Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.	Through Study Completion, An Average of 1 Year
Efficacy: Aneurysm Recanalization or Progressive Thrombosis	Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up	From Immediate Post Procedure Through Study Completion, An Average of 1 Year
Safety: Major Ipsilateral Stroke	Occurrence of Major Ipsilateral Stroke	Through Study Completion, An Average of 1 Year
Safety: Device-Related SAE	Device related SAE at final follow-up	Through Study Completion, An Average of 1 Year
Safety: All-cause Morbidity and Mortality	All-cause morbidity and mortality at final follow-up	Through Study Completion, An Average of 1 Year

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: Clemens M Schirmer, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): September 7, 2023
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CLP 13669

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No