Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

Phase 4WithdrawnNCT02079818

Penumbra Inc.

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Visceral Artery Aneurysms Arteriovenous Malformations

Interventions

Penumbra Ruby Coil SystemDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

1. Packing density with the number of coils implanted

Time frame: During the procedure

2. Time of fluoroscopic exposure

Time frame: During the procedure

3. Procedural device-related serious adverse events at immediate post-procedure

Time frame: At immediate post-procedure

4. Occlusion of the aneurysm sac or target vessel at immediate post-procedure

Time frame: At immediate post-procedure

5. Occlusion of the aneurysm sac or target vessel at one year post-procedure

Time frame: One year post-procedure

Secondary Outcomes

1. Recanalization of the aneurysm sac or target vessel at 4 months post-procedure

Time frame: 4 months post-procedure

Data from ClinicalTrials.gov

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