Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

Study Overview
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Brief Summary
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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.

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

Conditions
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Visceral Artery Aneurysms, Arteriovenous Malformations

Intervention / Treatment
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* Device: Penumbra Ruby Coil System


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Penumbra Ruby Coil System<br> | Device: Penumbra Ruby Coil System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visceral artery aneurysms, arteriovenous malformations, Penumbra Ruby Coil System