Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System
Sponsor
Penumbra Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02079818
Collaborator
(none)
0
1
1
15
0
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CLP 7463: Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System
Anticipated Study Start Date
:
Jun 1, 2017
Anticipated Primary Completion Date
:
Sep 1, 2018
Anticipated Study Completion Date
:
Sep 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Penumbra Ruby Coil System
|
Device: Penumbra Ruby Coil System
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 1. Recanalization of the aneurysm sac or target vessel at 4 months post-procedure [4 months post-procedure]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Penumbra Inc.
Investigators
- Principal Investigator: Paraq J Patel, MD, Medical College of Wisconsin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT02079818
Other Study ID Numbers:
- CLP 7463
First Posted:
Mar 6, 2014
Last Update Posted:
Apr 12, 2019
Last Verified:
Apr 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Penumbra Inc.
Additional relevant MeSH terms: