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

Completed

Conditions: Aneurysm, Brain

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

Registration Number: NCT04106583

Lead Sponsor: Penumbra Inc.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 572

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Efficacy: Adequate Occlusion	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.
Safety: Serious Adverse Events (SAEs)	Up to 24 Hours Post-Procedure	The primary safety endpoints are SAEs within 24 hours post-procedure
Safety: Device-Related SAE	Through Discharge, up to 7 Days Post-Procedure	Device-related SAE up to 7 days or discharge

Secondary Outcome Measures

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

Trial Locations

Locations (43): Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Vidant Medical Center
🇺🇸
Greenville, North Carolina, United States
Baylor University Medical Center
🇺🇸
Dallas, Texas, United States
Foothills Medical Center
🇨🇦
Calgary, Canada
Klinikum Chemnitz gGmbH
🇩🇪
Chemnitz, Germany
Maggiore della Carità
🇮🇹
Novara, Italy
Westchester Medical Center
🇺🇸
Valhalla, New York, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
Riverside Regional Medical Center
🇺🇸
Newport News, Virginia, United States
Amita Health
🇺🇸
Joliet, Illinois, United States
University of Miami (Jackson Memorial)
🇺🇸
Miami, Florida, United States
HRI - Swedish
🇺🇸
Englewood, Colorado, United States
UPenn
🇺🇸
Philadelphia, Pennsylvania, United States
Indiana University Health
🇺🇸
Indianapolis, Indiana, United States
Northwell Health
🇺🇸
Manhasset, New York, United States
Sharp Grossmont
🇺🇸
La Mesa, California, United States
Mercy St. Vincent
🇺🇸
Toledo, Ohio, United States
McAllen Medical Center
🇺🇸
McAllen, Texas, United States
Banner UMC Tucson
🇺🇸
Tucson, Arizona, United States
St. Anthony's Hospital
🇺🇸
Lakewood, Colorado, United States
Southeast Health Medical Center
🇺🇸
Dothan, Alabama, United States
Mount Sinai Hospital
🇺🇸
New York, New York, United States
SSM Health Care
🇺🇸
Bridgeton, Missouri, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Texas Stroke Institute - DFW
🇺🇸
Plano, Texas, United States
Vall d'Hebron
🇪🇸
Barcelona, Spain
Donostia
🇪🇸
San Sebastián, Spain
Los Robles
🇺🇸
Thousand Oaks, California, United States
Metro Health
🇺🇸
Wyoming, Michigan, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Bremen-Mitte
🇩🇪
Bremen, Germany
UKSH - Campus Lübeck
🇩🇪
Lübeck, Germany
Universitätsspital Basel
🇨🇭
Basel, Switzerland
Greenville Memorial Hospital
🇺🇸
Greenville, South Carolina, United States
University of Tennessee Medical Center, Knoxville
🇺🇸
Knoxville, Tennessee, United States
University Health Network
🇨🇦
Toronto, Canada
Yale New Haven
🇺🇸
New Haven, Connecticut, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Morton Plant
🇺🇸
Tampa, Florida, United States
Ochsner Medical Center
🇺🇸
New Orleans, Louisiana, United States
University of Oklahoma
🇺🇸
Oklahoma City, Oklahoma, United States
MUSC
🇺🇸
Charleston, South Carolina, United States