Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

Arteriovenous Malformations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02079818
• Other study ID #: CLP 7463
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 2017
• Est. completion date: September 2018

Study information

• Verified date: April 2019
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Visceral Artery Aneurysms

Intervention

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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Packing density with the number of coils implanted		During the procedure
Primary	2. Time of fluoroscopic exposure		During the procedure
Primary	3. Procedural device-related serious adverse events at immediate post-procedure		At immediate post-procedure
Primary	4. Occlusion of the aneurysm sac or target vessel at immediate post-procedure		At immediate post-procedure
Primary	5. Occlusion of the aneurysm sac or target vessel at one year post-procedure		One year post-procedure
Secondary	1. Recanalization of the aneurysm sac or target vessel at 4 months post-procedure		4 months post-procedure