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

Aneurysm, Brain Clinical Trial

— SURF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04106583
• Other study ID #: CLP 13669
• Status: Active, not recruiting
• Start date: November 5, 2019
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 575
• Est. completion date: August 2024
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Brain
• Intracranial Aneurysm

Intervention

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

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary
Canada	University Health Network	Toronto
Germany	Bremen-Mitte	Bremen
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	UKSH - Campus Lübeck	Lübeck
Italy	Maggiore della Carità	Novara
Spain	Vall d'Hebron	Barcelona
Spain	Donostia	San Sebastián
Switzerland	Universitätsspital Basel	Basel
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	SSM Health Care	Bridgeton	Missouri
United States	MUSC	Charleston	South Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Baylor University Medical Center	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Southeast Health Medical Center	Dothan	Alabama
United States	HRI - Swedish	Englewood	Colorado
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Vidant Medical Center	Greenville	North Carolina
United States	Indiana University Health	Indianapolis	Indiana
United States	Amita Health	Joliet	Illinois
United States	University of Tennessee Medical Center, Knoxville	Knoxville	Tennessee
United States	Sharp Grossmont	La Mesa	California
United States	St. Anthony's Hospital	Lakewood	Colorado
United States	Northwell Health	Manhasset	New York
United States	McAllen Medical Center	McAllen	Texas
United States	University of Miami (Jackson Memorial)	Miami	Florida
United States	Yale New Haven	New Haven	Connecticut
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Mount Sinai Hospital	New York	New York
United States	Riverside Regional Medical Center	Newport News	Virginia
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	UPenn	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Texas Stroke Institute - DFW	Plano	Texas
United States	Morton Plant	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Los Robles	Thousand Oaks	California
United States	Mercy St. Vincent	Toledo	Ohio
United States	Banner UMC Tucson	Tucson	Arizona
United States	Westchester Medical Center	Valhalla	New York
United States	Metro Health	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety: Serious Adverse Events (SAEs)	SAEs within 24 hours post-procedure	Up to 24 Hours Post-Procedure
Primary	Safety: Device-Related SAE	Device-related SAE up to 7 days or discharge	Through Discharge, up to 7 Days Post-Procedure
Secondary	Efficacy: Occlusion rate	Immediate post-procedure occlusion rates	Immediate Post-Procedure
Secondary	Efficacy: Retreatment Rate	Retreatment rate at final follow-up	Through Study Completion, An Average of 1 Year
Secondary	Efficacy: Aneurysm Occlusion Raymond I	Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.	Immediate Post-Treatment
Secondary	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
Secondary	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
Secondary	Safety: Major Ipsilateral Stroke	Occurrence of Major Ipsilateral Stroke	Through Study Completion, An Average of 1 Year
Secondary	Safety: Device-Related SAE	Device related SAE at final follow-up	Through Study Completion, An Average of 1 Year
Secondary	Safety: All-cause Morbidity and Mortality	All-cause morbidity and mortality at final follow-up	Through Study Completion, An Average of 1 Year