Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
- Conditions
- Intracranial Aneurysm
- 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
- 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)
Southeast Alabama Medical Center
🇺🇸Dothan, Alabama, United States
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
Scroll for more (62 remaining)Southeast Alabama Medical Center🇺🇸Dothan, Alabama, United States