Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02079818
Other study ID # CLP 7463
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date June 2017
Est. completion date September 2018

Study information

Verified date April 2019
Source Penumbra Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Medical College of Wisconsin Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1. Packing density with the number of coils implanted During the procedure
Primary 2. Time of fluoroscopic exposure During the procedure
Primary 3. Procedural device-related serious adverse events at immediate post-procedure At immediate post-procedure
Primary 4. Occlusion of the aneurysm sac or target vessel at immediate post-procedure At immediate post-procedure
Primary 5. Occlusion of the aneurysm sac or target vessel at one year post-procedure One year post-procedure
Secondary 1. Recanalization of the aneurysm sac or target vessel at 4 months post-procedure 4 months post-procedure
See also
  Status Clinical Trial Phase
Recruiting NCT03306823 - Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1 N/A
Recruiting NCT03306836 - Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2 N/A
Completed NCT01347307 - Stereotactic Body Radiotherapy for Spine Tumors N/A
Recruiting NCT02042326 - Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations Phase 2
Recruiting NCT05484245 - Sonography-guided Resection of Brain Mass Lesions N/A
Recruiting NCT05484219 - Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations N/A
Recruiting NCT05477680 - Intraoperative Brain Shift Calculation Study N/A
Completed NCT03656211 - Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation
Completed NCT04246125 - Patient Skin Dose in Interventional Radiology
Recruiting NCT02879071 - Long Term Follow-up After Embolization of Brain Arteriovenous Malformations
Terminated NCT01801488 - Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm N/A
Recruiting NCT06259292 - Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Recruiting NCT02098252 - Treatment of Brain AVMs (TOBAS) Study N/A
Completed NCT02378883 - Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study N/A
Completed NCT00783523 - Influence of MMP on Brain AVM Hemorrhage Phase 1
Recruiting NCT05276934 - Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)
Recruiting NCT03031873 - Evaluation of Susceptibility-weighted Magnetic Resonance Imaging and 4d-time-resolved Magnetic Resonance Angiography in Brain Arteriovenous Malformations N/A
Completed NCT01381952 - Image Quality and Radiation Dose in Angiography N/A
Active, not recruiting NCT05418816 - SelfWrap-Assisted Arteriovenous Fistulas N/A
Active, not recruiting NCT03559556 - Treating Arteriovenous Malformation With Stereotactic Radiosurgery Using CT Angiography for Treatment Planning Early Phase 1