Clinical Trials Directory

Trials / Terminated

TerminatedNCT02122133

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

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

Status
Terminated
Phase
Study type
Observational
Enrollment
67 (actual)
Sponsor
Penumbra Inc. · Industry
Sex
All
Age
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEPC 400

Timeline

Start date
2015-05-01
Primary completion
2016-10-19
Completion
2016-10-19
First posted
2014-04-24
Last updated
2019-04-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02122133. Inclusion in this directory is not an endorsement.