Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

Phase 4

Withdrawn

• Conditions: Visceral Artery Aneurysms; Arteriovenous Malformations
• Interventions: Device: Penumbra Ruby Coil System

• Registration Number: NCT02079818
• Lead Sponsor: Penumbra Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-06
• Study Start: 2017-06
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Penumbra Ruby Coil System	Penumbra Ruby Coil System	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States