Clinical trial NCT04106583: Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm, Brain
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-27
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: Adequate Occlusion
timeFrame: Through Study Completion, An Average of 1 Year
measure: Safety: Serious Adverse Events (SAEs)
timeFrame: Up to 24 Hours Post-Procedure
measure: Safety: Device-Related SAE
timeFrame: Through Discharge, up to 7 Days Post-Procedure
Secondary outcomes:
measure: Efficacy: Occlusion Rate
timeFrame: Immediate Post-Procedure
measure: Efficacy: Retreatment Rate
timeFrame: Through Study Completion, An Average of 1 Year
measure: Efficacy: Aneurysm Occlusion Raymond I
timeFrame: Immediate Post-Treatment
measure: Efficacy: Aneurysm Occlusion Raymond I
timeFrame: Through Study Completion, An Average of 1 Year
measure: Efficacy: Aneurysm Recanalization or Progressive Thrombosis
timeFrame: From Immediate Post Procedure Through Study Completion, An Average of 1 Year
measure: Safety: Major Ipsilateral Stroke
timeFrame: Through Study Completion, An Average of 1 Year
measure: Safety: Device-Related SAE
timeFrame: Through Study Completion, An Average of 1 Year
measure: Safety: Morbidity and Mortality
timeFrame: Through Study Completion, An Average of 1 Year
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Southeast Health Medical Center
state: Alabama
city: Tucson
country: United States
facility: Banner UMC Tucson
state: Arizona
city: La Mesa
country: United States
facility: Sharp Grossmont
state: California
city: Thousand Oaks
country: United States
facility: Los Robles
state: California
city: Englewood
country: United States
facility: HRI - Swedish
state: Colorado
city: Lakewood
country: United States
facility: St. Anthony's Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven
state: Connecticut
city: Miami
country: United States
facility: University of Miami (Jackson Memorial)
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: Morton Plant
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Joliet
country: United States
facility: Amita Health
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Wyoming
country: United States
facility: Metro Health
state: Michigan
city: Bridgeton
country: United States
facility: SSM Health Care
state: Missouri
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Toledo
country: United States
facility: Mercy St. Vincent
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: UPenn
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center, Knoxville
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: McAllen
country: United States
facility: McAllen Medical Center
state: Texas
city: Plano
country: United States
facility: Texas Stroke Institute - DFW
state: Texas
city: Newport News
country: United States
facility: Riverside Regional Medical Center
state: Virginia
city: Calgary
country: Canada
facility: Foothills Medical Center
city: Toronto
country: Canada
facility: University Health Network
city: Bremen
country: Germany
facility: Bremen-Mitte
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Lübeck
country: Germany
facility: UKSH - Campus Lübeck
city: Novara
country: Italy
facility: Maggiore della Carità
city: Barcelona
country: Spain
facility: Vall d'Hebron
city: San Sebastián
country: Spain
facility: Donostia
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
affiliation: Geisinger Clinic
name: Clemens M Schirmer, MD
role: PRINCIPAL_INVESTIGATOR
References: