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CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400

NCT02122133 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2019-04-12

No results posted yet for this study

Summary

The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the PC 400 or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.

Conditions

  • Intracranial Aneurysms

Interventions

DEVICE

PC 400

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Principal Investigators

  • Abhineet Chowdhary, MD · Director of Neuro-Interventional Surgery, Overlake Hospital Medical Center, Bellevue, WA 98004

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-10-19
Completion
2016-10-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02122133 on ClinicalTrials.gov