Trial Outcomes & Findings for The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms (NCT NCT01636453)

NCT ID: NCT01636453

Last Updated: 2018-08-23

Results Overview

Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: At 12 months post-implant
• Results posted on: 2018-08-23

Participant Flow

Participant milestones

Measure	Liberty Stent Arm Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Overall Study STARTED	120
Overall Study COMPLETED	112
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms

Baseline characteristics by cohort

Measure	Liberty Stent Arm n=112 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	27 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	17 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	61 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown	4 Participants n=5 Participants
Region of Enrollment United States	95 participants n=5 Participants
Region of Enrollment Japan	25 participants n=5 Participants
BMI	26.9 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: At 12 months post-implant

Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004).

Outcome measures

Measure	Liberty Stent Arm n=109 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Participants With Raymond Class I Complete Obliteration at 12 Months	98 Participants

PRIMARY outcome

Timeframe: At 12 months post-implant

Outcome measures

Measure	Liberty Stent Arm n=112 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.	3 Participants

SECONDARY outcome

Timeframe: At 12 months post-implant

Defined as episodes of focal or global neurological dysfunction due to brain or retinal infarction in the same hemisphere of the target aneurysm with signs and symptoms that persist for 24 hours or longer. When appropriate, non contrast CT scans will be used to eliminate hemorrhagic strokes

Outcome measures

Measure	Liberty Stent Arm n=112 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Ipsilateral Ischemic Strokes	8 participants

SECONDARY outcome

Timeframe: During the procedure

The number of participants with device-related Serious Adverse Events as a measure of safety of the procedure and device. The FDA definitions for Serious Adverse Events are used.

Outcome measures

Measure	Liberty Stent Arm n=112 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Participants With Device-related Serious Adverse Events	17 Participants

SECONDARY outcome

Timeframe: During the procedure

Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm

Outcome measures

Measure	Liberty Stent Arm n=112 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Device Deployment Failures	5 Participants

SECONDARY outcome

Timeframe: 12 months post-implant

Migration is defined as movement of the Liberty stent by more than 5 mm as documented by the 12 month angiogram when compared to its immediate post-implant position.

Outcome measures

Measure	Liberty Stent Arm n=105 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Device Migrations	0 Participants

SECONDARY outcome

Timeframe: At 12 months post-implant

Raymond Class I Occlusion grading defined as complete obliteration of the aneurysm at 12 months.

Outcome measures

Measure	Liberty Stent Arm n=109 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Participants With Aneurysm Raymond Class I Occlusion Grading	99 Participants

SECONDARY outcome

Timeframe: At 12 months post-implant

Inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhages (symptomatic or asymptomatic). Symptomatic is defined as a 4 point or more increase in the National Institutes of Health Stroke Scale (NIHSS) from baseline. The NIHSS ranges from 1 to 42, with higher scores indicating greater severity of stroke.

Outcome measures

Measure	Liberty Stent Arm n=112 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Intracranial Hemorrhages	2 Participants

SECONDARY outcome

Timeframe: At 12 months post-implant

The Modified Rankin Scale measures functional ability on a scale from 0-5, with 0 indicating no symptoms at all and 5 indicating severe disability.

Outcome measures

Measure	Liberty Stent Arm n=107 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2	106 Participants

SECONDARY outcome

Timeframe: At 12 months post-implant

Outcome measures

Measure	Liberty Stent Arm n=112 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
All Cause Mortality (Number of Deaths From Any Cause)	0 Participants

SECONDARY outcome

Timeframe: At 12 months post-implant

Defined as any intervention after the completion of the initial stent assisted coiling procedure

Outcome measures

Measure	Liberty Stent Arm n=112 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Retreatments	4 Participants

SECONDARY outcome

Timeframe: at 12 months post-implant

Device patency (stenosis) at 12 months

Outcome measures

Measure	Liberty Stent Arm n=105 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Participants Who Experienced Device Patency	2 Participants

SECONDARY outcome

Timeframe: At 12 months post-implant

Outcome measures

Measure	Liberty Stent Arm n=112 Participants Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Number of Participants Who Experienced Aneurysm Recanalization	6 Participants

Adverse Events

Liberty Stent Arm

Serious events: 34 serious events

Other events: 96 other events

Deaths: 0 deaths

Serious adverse events

Measure	Liberty Stent Arm n=112 participants at risk Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Nervous system disorders Nervous System Disorders	17.0% 19/112
Infections and infestations Infections and Infestations	6.2% 7/112
Gastrointestinal disorders Gastrointestinal Disorders	5.4% 6/112
General disorders General Disorders	5.4% 6/112
Cardiac disorders Cardiac Disorders	2.7% 3/112
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	2.7% 3/112
Blood and lymphatic system disorders Blood and Lymphatic System Disorders	1.8% 2/112
Eye disorders Eye Disorders	1.8% 2/112
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms, benign, malignant and unspecified	1.8% 2/112
Vascular disorders Vascular Disorders	1.8% 2/112
Hepatobiliary disorders Hepatobiliary Disorders	0.89% 1/112
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	0.89% 1/112
Psychiatric disorders Psychiatric Disorders	0.89% 1/112
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic, and mediastinal disorders	0.89% 1/112

Other adverse events

Measure	Liberty Stent Arm n=112 participants at risk Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Nervous system disorders Nervous System Disorders	53.6% 60/112
General disorders General Disorders	20.5% 23/112
Infections and infestations Infections and Infestations	19.6% 22/112
Eye disorders Eye Disorders	30.4% 34/112
Vascular disorders Vascular Disorders	13.4% 15/112
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	10.7% 12/112
Injury, poisoning and procedural complications Injury, poisoning, and procedural complications	9.8% 11/112
Musculoskeletal and connective tissue disorders Muskuloskeletal and connective tissue disorders	8.9% 10/112
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	8.0% 9/112
Blood and lymphatic system disorders Blood and lymphatic system disorders	5.4% 6/112
Cardiac disorders Cardiac disorders	5.4% 6/112
Immune system disorders Immune System Disorders	5.4% 6/112
Metabolism and nutrition disorders Metabolism and nutrition disorders	5.4% 6/112
Renal and urinary disorders Renal and urinary disorders	5.4% 6/112
Ear and labyrinth disorders Ear and labyrinth disorders	3.6% 4/112
Investigations Investigations	1.8% 2/112
Reproductive system and breast disorders Reproductive system and breast disorders	1.8% 2/112
Endocrine disorders Endrocrine disorders	0.89% 1/112
Psychiatric disorders Psychiatric Disorders	0.89% 1/112
Surgical and medical procedures Surgical and Medical Procedures	0.89% 1/112

Additional Information

Michaella Corso

Penumbra, Inc.

Phone: (510) 748-3200

Results disclosure agreements

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