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

NCT02122133 | Terminated

• 1 other identifier: CLP 7495
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

IC aneurysms, coil embolization, PC 400, radiation exposure,

Outcome Measures

Primary Outcomes (2)

• 1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time].

  Radiation exposure is measured by air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time.

  At immediate post-procedure

• 2. Procedural serious adverse events

  Procedural serious adverse events up until 3 days or discharge, whichever occurs first.

Study Arms (2)

PC 400

Patients treated with the PC 400 according to the IFU

Device: PC 400

Conventional Embolic Coils

These are any approved embolic coils on the market used as part of the standard of care for treating intracranial aneurysms.

Device: PC 400

Interventions

PC 400 DEVICE

Conventional Embolic Coils; PC 400

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients enrolled in the PC 400 arm must be those treated according to the cleared indication for the PC 400 System, which includes endovascular embolization of intracranial aneurysms.
• Patients treated with conventional coils should be treated per their IFU.
• Adjunctive use of stents, balloons or liquid embolics, if considered appropriate by investigators, is allowed.

You may not qualify if:

• Pre-planned use of multiple coil systems and/or flow diverters.

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (1)

Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Abhineet Chowdhary, MD

  Director of Neuro-Interventional Surgery, Overlake Hospital Medical Center, Bellevue, WA 98004

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 24, 2014
• Study Start: May 1, 2015
• Primary Completion: October 19, 2016
• Study Completion: October 19, 2016
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

US (1)