A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System

NCT01754051 | Completed

• 1 other identifier: CLP 4818
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.

Conditions

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (4)

• Packing density with the number of coils implanted

  During the procedure

• Time of fluoroscopic exposure

  During the procedure

• Procedural device-related serious adverse events at immediate post-procedure

  During the procedure

• Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale

  At 1 year post-procedure

Secondary Outcomes (2)

• Acute occlusion of the aneurysm sac at immediate post-procedure

  At immediate post-procedure

• Adverse events occurring during the procedure and in the 30±7 days following the treatment.

  During and at 30 days post-procedure

Study Arms (1)

Treatment by the PC 400 coils

Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System in the Instructions for Use.

Device: PC 400 coils

Interventions

PC 400 coils DEVICE

Treatment by the PC 400 coils

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 200 patients with intracranial aneurysms treated by the PC 400 System at up to 20 centers will be enrolled.

You may qualify if:

• Patients older than 18 years
• Intracranial aneurysms \>2mm, ruptured or unruptured

You may not qualify if:

• Fusiform aneurysms
• Dissecting aneurysms
• Aneurysms associated with brain AVMs
• Multiple aneurysms
• Re-treated aneurysms
• Patients in whom endovascular embolization therapies other than PC 400 System are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (1)

CHU Pellegrin

Bordeaux, France

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dr. Jérôme Berge, MD

  CHU Pellegrin - Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 21, 2012
• Study Start: January 1, 2013
• Primary Completion: October 3, 2017
• Study Completion: October 3, 2017
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

FR (1)