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Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by Penumbra Inc.
Information provided by (Responsible Party):
Penumbra Inc. Identifier:
First received: March 3, 2014
Last updated: December 22, 2016
Last verified: September 2016
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 Intervention Phase
Visceral Artery Aneurysms
Arteriovenous Malformations
Device: Penumbra Ruby Coil System
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CLP 7463: Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

Resource links provided by NLM:

Further study details as provided by Penumbra Inc.:

Primary Outcome Measures:
  • 1. Packing density with the number of coils implanted [ Time Frame: During the procedure ]
  • 2. Time of fluoroscopic exposure [ Time Frame: During the procedure ]
  • 3. Procedural device-related serious adverse events at immediate post-procedure [ Time Frame: At immediate post-procedure ]
  • 4. Occlusion of the aneurysm sac or target vessel at immediate post-procedure [ Time Frame: At immediate post-procedure ]
  • 5. Occlusion of the aneurysm sac or target vessel at one year post-procedure [ Time Frame: One year post-procedure ]

Secondary Outcome Measures:
  • 1. Recanalization of the aneurysm sac or target vessel at 4 months post-procedure [ Time Frame: 4 months post-procedure ]

Estimated Enrollment: 60
Study Start Date: June 2017
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02079818

Contact: Parag J Patel, MD 414-805-5200
Contact: Robert A Hieb, MD 414-805-3666

United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Parag J Patel, MD    414-805-5200   
Contact: Robert A Hieb, MD    414-805-3666   
Principal Investigator: Parag J Patel, MD         
Principal Investigator: Robert A Hieb, MD         
Sponsors and Collaborators
Penumbra Inc.
Principal Investigator: Paraq J Patel, MD Medical College of Wisconsin
  More Information

Responsible Party: Penumbra Inc. Identifier: NCT02079818     History of Changes
Other Study ID Numbers: CLP 7463
Study First Received: March 3, 2014
Last Updated: December 22, 2016

Keywords provided by Penumbra Inc.:
visceral artery aneurysms
arteriovenous malformations
Penumbra Ruby Coil System

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Vascular Diseases
Cardiovascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms processed this record on May 25, 2017