Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

April 10, 2019 updated by: Penumbra Inc.

CLP 7463: Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

The primary objective of this study is to gather post market data on the Penumbra Ruby Coil System in the treatment of visceral artery aneurysms and arteriovenous malformations. This study is a prospective, multi-center study of patients with visceral artery aneurysms and visceral arteriovenous malformations who are treated by the Penumbra Ruby Coil System. Data for each patient are collected up to 12 months post-procedure for the study.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients enrolled in this study must be those treated according to the cleared indication for the Penumbra Ruby Coil System for visceral arterial and venous embolizations.

Exclusion Criteria:

  • Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Penumbra Ruby Coil System
Device: Penumbra Ruby Coil System
The Penumbra Ruby™ Coil is a new generation of detachable coils developed by Penumbra Inc. This coil system is specifically designed for the occlusion of aneurysms and vessels that is equivalent to standard platinum coils. This system consists of: an implantable Coil attached to a Detachment Pusher as well as a Detachment Handle. The Detachment Pusher is comprised of a shaft with a radiopaque positioning marker, a Distal Detachment Tip, and a pull wire. The Detachment Handle is used to detach the Coil Implant from the Detachment Pusher. The Penumbra Ruby Coil is designed for endovascular embolization in the peripheral vasculature. Intended users for this device are physicians who have received appropriate training in interventional radiology and endovascular intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1. Packing density with the number of coils implanted
Time Frame: During the procedure
During the procedure
2. Time of fluoroscopic exposure
Time Frame: During the procedure
During the procedure
3. Procedural device-related serious adverse events at immediate post-procedure
Time Frame: At immediate post-procedure
At immediate post-procedure
4. Occlusion of the aneurysm sac or target vessel at immediate post-procedure
Time Frame: At immediate post-procedure
At immediate post-procedure
5. Occlusion of the aneurysm sac or target vessel at one year post-procedure
Time Frame: One year post-procedure
One year post-procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
1. Recanalization of the aneurysm sac or target vessel at 4 months post-procedure
Time Frame: 4 months post-procedure
4 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penumbra Inc.

Investigators

  • Principal Investigator: Paraq J Patel, MD, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2017

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (ESTIMATE)

March 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP 7463

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arteriovenous Malformations

Clinical Trials on Penumbra Ruby Coil System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe