Trial Outcomes & Findings for Study of the Penumbra Coil 400 System to Treat Aneurysm (NCT NCT01465841)

NCT ID: NCT01465841

Last Updated: 2020-07-07

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 517 participants
• Primary outcome timeframe: At immediate post-procedure
• Results posted on: 2020-07-07

Participant Flow

Participant milestones

Measure	Embolization With the PC 400 Coils 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 Study STARTED	517
Overall Study COMPLETED	449
Overall Study NOT COMPLETED	68

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Embolization With the PC 400 Coils n=517 Participants 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.
Age, Continuous	58.8 Years STANDARD_DEVIATION 14.4 • n=517 Participants
Sex: Female, Male Female	365 Participants n=517 Participants
Sex: Female, Male Male	152 Participants n=517 Participants

PRIMARY outcome

Timeframe: At immediate post-procedure

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

Outcome measures

Measure

Embolization With the PC 400 Coils n=416 Participants 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.

Packing Density With the Number of Coils Implanted

37.9 percentage of aneurysm volume Standard Deviation 15.9

PRIMARY outcome

Timeframe: At immediate post-procedure

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

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.

Outcome measures

Measure

Embolization With the PC 400 Coils n=533 lesions 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.

Time of Fluoroscopic Exposure

38.2 minutes Standard Deviation 28.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Embolization With the PC 400 Coils n=517 Participants 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.

Procedural Device-related Serious Adverse Events

12 events

SECONDARY outcome

Timeframe: At immediate post-procedure

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

Outcome measures

Measure	Embolization With the PC 400 Coils n=465 Participants 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.
Acute Occlusion of the Aneurysm Sac Raymond-Roy Occlusion Class I	214 participants
Acute Occlusion of the Aneurysm Sac Raymond-Roy Occlusion Class II	136 participants
Acute Occlusion of the Aneurysm Sac Raymond-Roy Occlusion Class III	115 participants

SECONDARY outcome

Timeframe: At discharge or 3 days post-procedure

Outcome measures

Measure

Embolization With the PC 400 Coils n=517 Participants 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.

Intracranial Hemorrhage

4 events

Adverse Events

Embolization With the PC 400 Coils

Serious events: 126 serious events

Other events: 284 other events

Deaths: 32 deaths

Serious adverse events

Measure	Embolization With the PC 400 Coils n=517 participants at risk 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.
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.58% 3/517 • up to 1 year in accordance to the standard of care at participating hospitals
Cardiac disorders Cardiac Disorders	1.9% 10/517 • up to 1 year in accordance to the standard of care at participating hospitals
Congenital, familial and genetic disorders Congenital, familial, and genetic disorders	0.19% 1/517 • up to 1 year in accordance to the standard of care at participating hospitals
Eye disorders Eye Disorders	0.19% 1/517 • up to 1 year in accordance to the standard of care at participating hospitals
Gastrointestinal disorders Gastrointestinal Disorders	2.9% 15/517 • up to 1 year in accordance to the standard of care at participating hospitals
General disorders General Disorders and Administration Site Conditions	2.7% 14/517 • up to 1 year in accordance to the standard of care at participating hospitals
Hepatobiliary disorders Hepatobiliary Disorders	0.58% 3/517 • up to 1 year in accordance to the standard of care at participating hospitals
Infections and infestations Infections and Infestations	3.3% 17/517 • up to 1 year in accordance to the standard of care at participating hospitals
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	1.9% 10/517 • up to 1 year in accordance to the standard of care at participating hospitals
Investigations Investigations	0.19% 1/517 • up to 1 year in accordance to the standard of care at participating hospitals
Metabolism and nutrition disorders Metabolism and Nutrition Disorders	0.97% 5/517 • up to 1 year in accordance to the standard of care at participating hospitals
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective Tissue Disorders	0.58% 3/517 • up to 1 year in accordance to the standard of care at participating hospitals
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant and Unspecified (incl cysts and polyps)	1.4% 7/517 • up to 1 year in accordance to the standard of care at participating hospitals
Nervous system disorders Nervous System Disorders	12.2% 63/517 • up to 1 year in accordance to the standard of care at participating hospitals
Psychiatric disorders Psychiatric Disorders	0.58% 3/517 • up to 1 year in accordance to the standard of care at participating hospitals
Renal and urinary disorders Renal and Urinary Disorders	0.39% 2/517 • up to 1 year in accordance to the standard of care at participating hospitals
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic and Mediastinal Disorders	2.7% 14/517 • up to 1 year in accordance to the standard of care at participating hospitals
Surgical and medical procedures Surgical and Medical Procedures	0.39% 2/517 • up to 1 year in accordance to the standard of care at participating hospitals
Vascular disorders Vascular Disorders	3.9% 20/517 • up to 1 year in accordance to the standard of care at participating hospitals

Other adverse events

Measure	Embolization With the PC 400 Coils n=517 participants at risk 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.
Blood and lymphatic system disorders Blood and lymphatic system disorders	1.9% 10/517 • up to 1 year in accordance to the standard of care at participating hospitals
Cardiac disorders Cardiac Disorders	4.3% 22/517 • up to 1 year in accordance to the standard of care at participating hospitals
Congenital, familial and genetic disorders Congenital, familial, and genetic disorders	0.19% 1/517 • up to 1 year in accordance to the standard of care at participating hospitals
Ear and labyrinth disorders Ear and Labyrinth Disorders	0.58% 3/517 • up to 1 year in accordance to the standard of care at participating hospitals
Endocrine disorders Endocrine Disorders	0.19% 1/517 • up to 1 year in accordance to the standard of care at participating hospitals
Eye disorders Eye Disorders	3.9% 20/517 • up to 1 year in accordance to the standard of care at participating hospitals
Gastrointestinal disorders Gastrointestinal Disorders	9.1% 47/517 • up to 1 year in accordance to the standard of care at participating hospitals
General disorders General Disorders and Administration Site Conditions	12.6% 65/517 • up to 1 year in accordance to the standard of care at participating hospitals
Hepatobiliary disorders Hepatobiliary Disorders	0.77% 4/517 • up to 1 year in accordance to the standard of care at participating hospitals
Immune system disorders Immune System Disorders	0.19% 1/517 • up to 1 year in accordance to the standard of care at participating hospitals
Infections and infestations Infections and Infestations	8.3% 43/517 • up to 1 year in accordance to the standard of care at participating hospitals
Injury, poisoning and procedural complications Injury, Poisoning, and Procedural Complications	5.0% 26/517 • up to 1 year in accordance to the standard of care at participating hospitals
Investigations Investigations	2.5% 13/517 • up to 1 year in accordance to the standard of care at participating hospitals
Metabolism and nutrition disorders Metabolism and Nutrition Disorders	4.1% 21/517 • up to 1 year in accordance to the standard of care at participating hospitals
Musculoskeletal and connective tissue disorders Muskuloskeletal and Connective Tissue Disorders	3.5% 18/517 • up to 1 year in accordance to the standard of care at participating hospitals
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant, and Unspecified (inc cysts and polyps)	2.1% 11/517 • up to 1 year in accordance to the standard of care at participating hospitals
Nervous system disorders Nervous System Disorders	30.9% 160/517 • up to 1 year in accordance to the standard of care at participating hospitals
Psychiatric disorders Psychiatric Disorders	4.3% 22/517 • up to 1 year in accordance to the standard of care at participating hospitals
Renal and urinary disorders Renal and Urinary Disorders	2.3% 12/517 • up to 1 year in accordance to the standard of care at participating hospitals
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic and Mediastinal Disorders	5.8% 30/517 • up to 1 year in accordance to the standard of care at participating hospitals
Skin and subcutaneous tissue disorders Skin and Subcutaneous Tissue Disorders	1.5% 8/517 • up to 1 year in accordance to the standard of care at participating hospitals
Surgical and medical procedures Surgical and Medical Procedures	0.77% 4/517 • up to 1 year in accordance to the standard of care at participating hospitals
Vascular disorders Vascular Disorders	10.1% 52/517 • up to 1 year in accordance to the standard of care at participating hospitals

Additional Information

Michaella Corso

Penumbra, Inc.

Phone: 415-815-8904

Email: mcorso@penumbrainc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place