WithdrawnPhase 4

Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

Stopped: The study was never initiated.

United States0Started 2017-06

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

1. Packing density with the number of coils implanted

Timeframe: During the procedure

2. Time of fluoroscopic exposure

Timeframe: During the procedure

3. Procedural device-related serious adverse events at immediate post-procedure

Timeframe: At immediate post-procedure

4. Occlusion of the aneurysm sac or target vessel at immediate post-procedure

Timeframe: At immediate post-procedure

5. Occlusion of the aneurysm sac or target vessel at one year post-procedure

Timeframe: One year post-procedure

Trial details

NCT IDNCT02079818

SponsorPenumbra Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09

View on ClinicalTrials.gov More Visceral Artery Aneurysms trials