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Completed

NCT Number: NCT01465841

Study of the Penumbra Coil 400 System to Treat Aneurysm

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hoag Hospital, Newport Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Packing Density With the Number of Coils Implanted

    Time frame: At immediate post-procedure

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

  2. Time of Fluoroscopic Exposure

    Time frame: At immediate post-procedure

    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.

  3. Procedural Device-related Serious Adverse Events

    Time frame: At immediate post-procedure

    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.

Secondary outcomes

  1. Acute Occlusion of the Aneurysm Sac

    Time frame: At immediate post-procedure

    Measured using Raymond Roy classification where grading ranges from I to III and higher values represent a worse outcome.

  2. Intracranial Hemorrhage

    Time frame: At discharge or 3 days post-procedure

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Official study title

ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System

Acronym: ACE

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2011
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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