Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
- Conditions
- Intracranial Aneurysm
- Interventions
- Device: Penumbra Smart CoilDevice: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
- Registration Number
- NCT02729740
- Lead Sponsor
- Penumbra Inc.
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 995
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Penumbra Smart System Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD) - Penumbra Smart System Penumbra Smart Coil -
- Primary Outcome Measures
Name Time Method Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout Immediate Post Procedure Re-access attempts due to catheter kick-out across all coils
Number of Participants Achieving Adequate Occlusion Immediate Post Procedure Immediate Post Procedure Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.
Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure Immediate Post Procedure Number of Participants Requiring Retreatment Through Follow-up One year from enrollment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (72)
Northwestern Memorial
🇺🇸Chicago, Illinois, United States
Allegheny General
🇺🇸Pittsburgh, Pennsylvania, United States
Houston Methodist
🇺🇸Houston, Texas, United States
Banner Desert Medical Center
🇺🇸Mesa, Arizona, United States
Banner - University Medical Center Tucson
🇺🇸Tucson, Arizona, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Bayfront Medical Center
🇺🇸Saint Petersburg, Florida, United States
Westside Regional Medical Center
🇺🇸Plantation, Florida, United States
St. Mary's Hospital
🇺🇸West Palm Beach, Florida, United States
Overlook Medical Center
🇺🇸Summit, New Jersey, United States
Royal University
🇨🇦Saskatoon, Canada
KUMC
🇺🇸Kansas City, Kansas, United States
Mt. Sinai Miami
🇺🇸Miami, Florida, United States
RIA - Lutheran Medical Center
🇺🇸Wheat Ridge, Colorado, United States
RIA - Swedish Medical Center
🇺🇸Englewood, Colorado, United States
St. Anthony's Hospital
🇺🇸Lakewood, Colorado, United States
Banner University Medical Center - Phoenix
🇺🇸Phoenix, Arizona, United States
BNI
🇺🇸Phoenix, Arizona, United States
OUHSC
🇺🇸Oklahoma City, Oklahoma, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Southeast Alabama Medical Center
🇺🇸Dothan, Alabama, United States
Community Regional
🇺🇸Fresno, California, United States
Loma Linda Medical Center
🇺🇸Loma Linda, California, United States
Cottage Hospital
🇺🇸Santa Barbara, California, United States
Lawnwood Regional Medical Center
🇺🇸Fort Pierce, Florida, United States
Christiana Health
🇺🇸Newark, Delaware, United States
CARE - Palmetto
🇺🇸Hialeah, Florida, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Jackson Memorial
🇺🇸Miami, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
WellStar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
St. Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
Clinical Radiologist
🇺🇸Springfield, Illinois, United States
North Shore University
🇺🇸Evanston, Illinois, United States
UHS Wilson Medical Center
🇺🇸Johnson City, New York, United States
HCMC
🇺🇸Minneapolis, Minnesota, United States
UM-Fairview
🇺🇸Minneapolis, Minnesota, United States
SSM Health Care
🇺🇸Fenton, Missouri, United States
Kaleida Health
🇺🇸Buffalo, New York, United States
Northshore
🇺🇸Manhasset, New York, 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
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
St. Vincent
🇺🇸Toledo, Ohio, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
Hershey's Medical Center
🇺🇸Hershey, Pennsylvania, United States
Palmetto Health
🇺🇸Columbia, South Carolina, United States
Methodist
🇺🇸Memphis, Tennessee, United States
Fort Sanders Regional Medical Center
🇺🇸Knoxville, Tennessee, United States
Baptist Hospital
🇺🇸Memphis, Tennessee, United States
Valley Baptist Medical Center
🇺🇸Harlingen, Texas, United States
Texas Stroke Institute
🇺🇸Plano, Texas, United States
Dept. of Neurosurgery, Univ of VA School of Medicine
🇺🇸Charlottesville, Virginia, United States
Overlake Hospital
🇺🇸Bellevue, Washington, United States
Valley Health Winchester
🇺🇸Winchester, Virginia, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Tacoma General
🇺🇸Tacoma, Washington, United States
Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Mercy San Juan
🇺🇸Sacramento, California, United States
MUSC
🇺🇸Charleston, South Carolina, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Erlanger Health System, University of TN College of Medicine
🇺🇸Chattanooga, Tennessee, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States