Study of the Penumbra Coil 400 System to Treat Aneurysm

NCT01465841 | Completed Results

• 1 other identifier: CLP 4492
• Study Type: interventional
• Target: 517
• Locations: 1 country
• Sites: 6

Brief Summary

This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital.

Conditions

Intracranial Aneurysms; Peripheral Aneurysms

Keywords

intracranial aneurysms; Peripheral aneurysms; acute treatment; PC 400 System; packing density

Outcome Measures

Primary Outcomes (3)

• Packing Density With the Number of Coils Implanted

  The data will be captured at the end of the coiling procedure which is standard for aneurysm studies.

  At immediate post-procedure

• Time of Fluoroscopic Exposure

  The total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coiling procedure.

  At immediate post-procedure

• Procedural Device-related Serious Adverse Events

  Procedural on-the-table serious adverse events will be captured and recorded at the end of the procedure. The duration of the procedure can be variable, depending on the time to access the target lesion and the time to complete the coiling procedure.

  At immediate post-procedure

Secondary Outcomes (2)

• Acute Occlusion of the Aneurysm Sac

  At immediate post-procedure

• Intracranial Hemorrhage

  At discharge or 3 days post-procedure

Study Arms (1)

Embolization with the PC 400 coils

EXPERIMENTAL

Device: PC 400 coils (Penumbra )

Interventions

PC 400 coils (Penumbra ) DEVICE

The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip.

Embolization with the PC 400 coils

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System which is for the endovascular embolization of:
• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature

You may not qualify if:

• Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (6)

Hoag Hospital

Newport Beach, California, 92658-6100, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612-3833, United States

Location

Mount Sinai School of Medicine

New York, New York, NY 10029, United States

Location

State University of New York Upstate Medical Center

Syracuse, New York, 13210, United States

Location

Fort Sanders Medical Center

Knoxville, Tennessee, 37916, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

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

Results Point of Contact

• Title: Michaella Corso
• Organization: Penumbra, Inc.

mcorso@penumbrainc.com

415-815-8904

Study Officials

• Siu P Sit, PhD

  Penumbra Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 7, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 7, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-06

Locations

US (6)