Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Penumbra Inc.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT02079818
First received: March 3, 2014
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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: Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: No ]
  • 2. Time of fluoroscopic exposure [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]
  • 3. Procedural device-related serious adverse events at immediate post-procedure [ Time Frame: At immediate post-procedure ] [ Designated as safety issue: Yes ]
  • 4. Occlusion of the aneurysm sac or target vessel at immediate post-procedure [ Time Frame: At immediate post-procedure ] [ Designated as safety issue: Yes ]
  • 5. Occlusion of the aneurysm sac or target vessel at one year post-procedure [ Time Frame: One year post-procedure ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 60
Study Start Date: April 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: April 2016 (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.

  Eligibility

Genders Eligible for Study:   Both
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.
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT02079818     History of Changes
Other Study ID Numbers: CLP 7463
Study First Received: March 3, 2014
Last Updated: March 4, 2014
Health Authority: USA: Human Research Protections Program, MCW and FMLH

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

Additional relevant MeSH terms:
Arteriovenous Malformations
Aneurysm
Congenital Abnormalities
Hemangioma
Vascular Diseases
Cardiovascular Diseases
Vascular Malformations
Cardiovascular Abnormalities
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014