Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

NCT02079818 | Withdrawn Phase 4 FDA Device

• 1 other identifier: CLP 7463
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Visceral Artery Aneurysms; Arteriovenous Malformations

Keywords

visceral artery aneurysms; arteriovenous malformations; Penumbra Ruby Coil System

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• 1. Recanalization of the aneurysm sac or target vessel at 4 months post-procedure

  4 months post-procedure

Study Arms (1)

Penumbra Ruby Coil System

EXPERIMENTAL

Device: Penumbra Ruby Coil System

Interventions

Penumbra Ruby Coil System DEVICE

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.

Penumbra Ruby Coil System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study.

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Paraq J Patel, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 6, 2014
• Study Start: June 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

US (1)