Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil

Intracranial Aneurysm Clinical Trial

— SMART  

Official title:

SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729740
• Other study ID #: CLP 10023
• Status: Completed
• Phase: N/A
• Start date: June 3, 2016
• Est. completion date: December 27, 2019

Study information

• Verified date: February 2021
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.

Description:

This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart System (Smart), Penumbra Coil 400TM (PC 400), and Penumbra Occlusion Device (POD®). Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up. Approximately 1,000 patients with intracranial aneurysms or other malformations treated by the Smart System at up to 100 centers will be enrolled. It is anticipated patient enrollment will take 3 years. All patients are to be assessed in accordance with the standard of care at each participating hospital through one year follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 995
• Est. completion date: December 27, 2019
• Est. primary completion date: December 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients enrolled in this study must sign the Informed Consent Form and be treated according to the cleared indications for the Smart, PC 400, and POD, which include the embolization of:

• Intracranial aneurysms

• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae

Exclusion Criteria:

• Life expectancy less than one year

• Smart, PC 400, or POD account for less than 75% of total number of coils implanted

• Participation in another clinical investigation that could confound the evaluation of the registry device

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Penumbra Smart Coil

• Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
Other Penumbra Coils available as standard of care

Locations

Country	Name	City	State
Canada	Royal University	Saskatoon
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	University of Colorado	Aurora	Colorado
United States	Overlake Hospital	Bellevue	Washington
United States	St. Alphonsus Regional Medical Center	Boise	Idaho
United States	Kaleida Health	Buffalo	New York
United States	MUSC	Charleston	South Carolina
United States	Dept. of Neurosurgery, Univ of VA School of Medicine	Charlottesville	Virginia
United States	Erlanger Health System, University of TN College of Medicine	Chattanooga	Tennessee
United States	Northwestern Memorial	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Palmetto Health	Columbia	South Carolina
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Southeast Alabama Medical Center	Dothan	Alabama
United States	RIA - Swedish Medical Center	Englewood	Colorado
United States	North Shore University	Evanston	Illinois
United States	SSM Health Care	Fenton	Missouri
United States	Lawnwood Regional Medical Center	Fort Pierce	Florida
United States	Community Regional	Fresno	California
United States	Valley Baptist Medical Center	Harlingen	Texas
United States	Hershey's Medical Center	Hershey	Pennsylvania
United States	CARE - Palmetto	Hialeah	Florida
United States	Memorial Healthcare System	Hollywood	Florida
United States	Houston Methodist	Houston	Texas
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Baptist Medical Center	Jacksonville	Florida
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	UHS Wilson Medical Center	Johnson City	New York
United States	KUMC	Kansas City	Kansas
United States	Fort Sanders Regional Medical Center	Knoxville	Tennessee
United States	Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	St. Anthony's Hospital	Lakewood	Colorado
United States	Loma Linda Medical Center	Loma Linda	California
United States	University of Louisville	Louisville	Kentucky
United States	Northshore	Manhasset	New York
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Baptist Hospital	Memphis	Tennessee
United States	Methodist	Memphis	Tennessee
United States	Banner Desert Medical Center	Mesa	Arizona
United States	Jackson Memorial	Miami	Florida
United States	Mt. Sinai Miami	Miami	Florida
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	HCMC	Minneapolis	Minnesota
United States	UM-Fairview	Minneapolis	Minnesota
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	Faxton St. Luke's Hospital	New Hartford	New York
United States	Mount Sinai	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Christiana Health	Newark	Delaware
United States	OUHSC	Oklahoma City	Oklahoma
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Banner University Medical Center - Phoenix	Phoenix	Arizona
United States	BNI	Phoenix	Arizona
United States	Allegheny General	Pittsburgh	Pennsylvania
United States	Texas Stroke Institute	Plano	Texas
United States	Westside Regional Medical Center	Plantation	Florida
United States	University of Rochester Medical Center	Rochester	New York
United States	Mercy San Juan	Sacramento	California
United States	Bayfront Medical Center	Saint Petersburg	Florida
United States	Cottage Hospital	Santa Barbara	California
United States	Clinical Radiologist	Springfield	Illinois
United States	Stony Brook University	Stony Brook	New York
United States	Overlook Medical Center	Summit	New Jersey
United States	Tacoma General	Tacoma	Washington
United States	University of South Florida	Tampa	Florida
United States	St. Vincent	Toledo	Ohio
United States	Banner - University Medical Center Tucson	Tucson	Arizona
United States	St. Mary's Hospital	West Palm Beach	Florida
United States	RIA - Lutheran Medical Center	Wheat Ridge	Colorado
United States	Valley Health Winchester	Winchester	Virginia
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	Metro Health Hospital	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Achieving Adequate Occlusion Immediate Post Procedure	Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.	Immediate Post Procedure
Primary	Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout	Re-access attempts due to catheter kick-out across all coils	Immediate Post Procedure
Primary	Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure		Immediate Post Procedure
Primary	Number of Participants Requiring Retreatment Through Follow-up		One year from enrollment