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

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

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

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