NCT02079818

Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Penumbra Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Visceral Artery Aneurysms
• Arteriovenous Malformations

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2014-03-06
• Last updated: 2019-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study