Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

Penumbra

Status and phase: Withdrawn; Phase 4

Conditions: Arteriovenous Malformations; Visceral Artery Aneurysms

Treatments: Device: Penumbra Ruby Coil System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02079818

CLP 7463

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Penumbra Ruby Coil System

Experimental group

Treatment:

Device: Penumbra Ruby Coil System