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

Completed · Not applicable

Conditions studied: Intracranial Aneurysm

In brief

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.

Key facts

Study ID

NCT02729740

Run by

Penumbra Inc.

People needed

995

Starts

2016-06-03

Expected to finish

2019-12-27

Last updated by the study team

2021-03-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner Desert Medical Center — Mesa, Arizona, United States
• Banner University Medical Center - Phoenix — Phoenix, Arizona, United States
• BNI — Phoenix, Arizona, United States
• Banner - University Medical Center Tucson — Tucson, Arizona, United States
• Community Regional — Fresno, California, United States
• Loma Linda Medical Center — Loma Linda, California, United States
• Mercy San Juan — Sacramento, California, United States
• Cottage Hospital — Santa Barbara, California, United States
• University of Colorado — Aurora, Colorado, United States
• RIA - Swedish Medical Center — Englewood, Colorado, United States
• St. Anthony's Hospital — Lakewood, Colorado, United States
• RIA - Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Christiana Health — Newark, Delaware, United States
• Lawnwood Regional Medical Center — Ft. Pierce, Florida, United States
• CARE - Palmetto — Hialeah, Florida, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• Baptist Medical Center — Jacksonville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Jackson Memorial — Miami, Florida, United States
• Mt. Sinai Miami — Miami, Florida, United States
• Westside Regional Medical Center — Plantation, Florida, United States
• Bayfront Medical Center — St. Petersburg, Florida, United States
• University of South Florida — Tampa, Florida, United States
• St. Mary's Hospital — West Palm Beach, Florida, United States
• Southeast Alabama Medical Center — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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