ACE: Study of the Penumbra Coil 400 System to Treat Aneurysm

• Sponsor: Penumbra Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01465841
• Collaborator: (none)
• Enrollment: 517
• Locations: 6
• Arm: 1
• Duration (Months): 67
• Patients Per Site: 86.2
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysms; Peripheral Aneurysms	Device: PC 400 coils (Penumbra )	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 517 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Embolization with the PC 400 coils

Device: PC 400 coils (Penumbra ); 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.

Outcome Measures

Primary Outcome Measures

1. Packing Density With the Number of Coils Implanted [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 [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 [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 Outcome Measures

1. Acute Occlusion of the Aneurysm Sac [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 [At discharge or 3 days post-procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hoag Hospital	Newport Beach	California	United States	92658-6100
2	Rush University Medical Center	Chicago	Illinois	United States	60612-3833
3	Mount Sinai School of Medicine	New York	New York	United States	NY 10029
4	State University of New York Upstate Medical Center	Syracuse	New York	United States	13210
5	Fort Sanders Medical Center	Knoxville	Tennessee	United States	37916
6	The Methodist Hospital Research Institute	Houston	Texas	United States	77030

Sponsors and Collaborators

• Penumbra Inc.

Investigators

• Study Director: Siu P Sit, PhD, Penumbra Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 10, 2011

More Information

Publications

None provided.

• Responsible Party: Penumbra Inc.
• ClinicalTrials.gov Identifier: NCT01465841
• Other Study ID Numbers: CLP 4492; CLP 4492
• First Posted: Nov 6, 2011
• Last Update Posted: Jul 7, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by Penumbra Inc.: intracranial aneurysms; Peripheral aneurysms; acute treatment; PC 400 System; packing density
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

Participant Flow

Arm/Group Title	Embolization With the PC 400 Coils
Arm/Group Description	PC 400 coils (Penumbra ): 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.
Period Title: Overall Study
STARTED	517
COMPLETED	449
NOT COMPLETED	68

Baseline Characteristics

Arm/Group Title	Embolization With the PC 400 Coils
Arm/Group Description	PC 400 coils (Penumbra ): 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.
Overall Participants	517
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.8 (14.4)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	58.8 (14.4)
Sex: Female, Male (Count of Participants)
Female	365 70.6%
Male	152 29.4%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Packing Density With the Number of Coils Implanted
Description	The data will be captured at the end of the coiling procedure which is standard for aneurysm studies.
Time Frame	At immediate post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolization With the PC 400 Coils
Arm/Group Description	PC 400 coils (Penumbra ): 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.
Measure Participants	416
Mean (Standard Deviation) [percentage of aneurysm volume]	37.9 (15.9)

2. Primary Outcome

Title	Time of Fluoroscopic Exposure
Description	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.
Time Frame	At immediate post-procedure

Outcome Measure Data

Analysis Population Description

The analysis population includes all intent-to-treat population. Procedural fluoroscopy time was available for 533 subjects.

Arm/Group Title	Embolization With the PC 400 Coils
Arm/Group Description	PC 400 coils (Penumbra ): 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.
Measure Participants	517
Measure lesions	533
Mean (Standard Deviation) [minutes]	38.2 (28.9)

3. Primary Outcome

Title	Procedural Device-related Serious Adverse Events
Description	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.
Time Frame	At immediate post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolization With the PC 400 Coils
Arm/Group Description	PC 400 coils (Penumbra ): 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.
Measure Participants	517
Number [events]	12

4. Secondary Outcome

Title	Acute Occlusion of the Aneurysm Sac
Description	Measured using Raymond Roy classification where grading ranges from I to III and higher values represent a worse outcome.
Time Frame	At immediate post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolization With the PC 400 Coils
Arm/Group Description	PC 400 coils (Penumbra ): 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.
Measure Participants	465
Raymond-Roy Occlusion Class I	214 41.4%
Raymond-Roy Occlusion Class II	136 26.3%
Raymond-Roy Occlusion Class III	115 22.2%

5. Secondary Outcome

Title	Intracranial Hemorrhage
Time Frame	At discharge or 3 days post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embolization With the PC 400 Coils
Arm/Group Description	PC 400 coils (Penumbra ): 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.
Measure Participants	517
Number [events]	4

Adverse Events

Time Frame	up to 1 year in accordance to the standard of care at participating hospitals
Arm/Group Title	Embolization With the PC 400 Coils
Arm/Group Description	PC 400 coils (Penumbra ): 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.
All Cause Mortality
	Embolization With the PC 400 Coils
	Affected / at Risk (%)	# Events
Total	32/517 (6.2%)
Serious Adverse Events
	Embolization With the PC 400 Coils
	Affected / at Risk (%)	# Events
Total	126/517 (24.4%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	3/517 (0.6%)
Cardiac disorders
Cardiac Disorders	10/517 (1.9%)
Congenital, familial and genetic disorders
Congenital, familial, and genetic disorders	1/517 (0.2%)
Eye disorders
Eye Disorders	1/517 (0.2%)
Gastrointestinal disorders
Gastrointestinal Disorders	15/517 (2.9%)
General disorders
General Disorders and Administration Site Conditions	14/517 (2.7%)
Hepatobiliary disorders
Hepatobiliary Disorders	3/517 (0.6%)
Infections and infestations
Infections and Infestations	17/517 (3.3%)
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications	10/517 (1.9%)
Investigations
Investigations	1/517 (0.2%)
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders	5/517 (1%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders	3/517 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant and Unspecified (incl cysts and polyps)	7/517 (1.4%)
Nervous system disorders
Nervous System Disorders	63/517 (12.2%)
Psychiatric disorders
Psychiatric Disorders	3/517 (0.6%)
Renal and urinary disorders
Renal and Urinary Disorders	2/517 (0.4%)
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders	14/517 (2.7%)
Surgical and medical procedures
Surgical and Medical Procedures	2/517 (0.4%)
Vascular disorders
Vascular Disorders	20/517 (3.9%)
Other (Not Including Serious) Adverse Events
	Embolization With the PC 400 Coils
	Affected / at Risk (%)	# Events
Total	284/517 (54.9%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	10/517 (1.9%)
Cardiac disorders
Cardiac Disorders	22/517 (4.3%)
Congenital, familial and genetic disorders
Congenital, familial, and genetic disorders	1/517 (0.2%)
Ear and labyrinth disorders
Ear and Labyrinth Disorders	3/517 (0.6%)
Endocrine disorders
Endocrine Disorders	1/517 (0.2%)
Eye disorders
Eye Disorders	20/517 (3.9%)
Gastrointestinal disorders
Gastrointestinal Disorders	47/517 (9.1%)
General disorders
General Disorders and Administration Site Conditions	65/517 (12.6%)
Hepatobiliary disorders
Hepatobiliary Disorders	4/517 (0.8%)
Immune system disorders
Immune System Disorders	1/517 (0.2%)
Infections and infestations
Infections and Infestations	43/517 (8.3%)
Injury, poisoning and procedural complications
Injury, Poisoning, and Procedural Complications	26/517 (5%)
Investigations
Investigations	13/517 (2.5%)
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders	21/517 (4.1%)
Musculoskeletal and connective tissue disorders
Muskuloskeletal and Connective Tissue Disorders	18/517 (3.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant, and Unspecified (inc cysts and polyps)	11/517 (2.1%)
Nervous system disorders
Nervous System Disorders	160/517 (30.9%)
Psychiatric disorders
Psychiatric Disorders	22/517 (4.3%)
Renal and urinary disorders
Renal and Urinary Disorders	12/517 (2.3%)
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders	30/517 (5.8%)
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders	8/517 (1.5%)
Surgical and medical procedures
Surgical and Medical Procedures	4/517 (0.8%)
Vascular disorders
Vascular Disorders	52/517 (10.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.