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Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

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ClinicalTrials.gov Identifier: NCT02079818
Recruitment Status : Not yet recruiting
First Posted : March 6, 2014
Last Update Posted : December 26, 2016
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

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
Visceral Artery Aneurysms Arteriovenous Malformations Device: Penumbra Ruby Coil System Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : June 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079818


Contacts
Contact: Parag J Patel, MD 414-805-5200 papatel@mcw.edu
Contact: Robert A Hieb, MD 414-805-3666 rhieb@mcw.edu

Locations
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Parag J Patel, MD    414-805-5200    papatel@mcw.edu   
Contact: Robert A Hieb, MD    414-805-3666    rhieb@mcw.edu   
Principal Investigator: Parag J Patel, MD         
Principal Investigator: Robert A Hieb, MD         
Sponsors and Collaborators
Penumbra Inc.
Investigators
Principal Investigator: Paraq J Patel, MD Medical College of Wisconsin

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT02079818     History of Changes
Other Study ID Numbers: CLP 7463
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: September 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
Aneurysm
Hemangioma
Vascular Diseases
Cardiovascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms