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

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ClinicalTrials.gov Identifier: NCT01636453
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Wide-neck, Saccular Intracranial Aneurysms
Intervention Device: Stent assisted coiling with the Liberty Stent
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description

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

Period Title: Overall Study
Started 120
Completed 112
Not Completed 8
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description

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 Number of Baseline Participants 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
<=18 years
0
   0.0%
Between 18 and 65 years
78
  69.6%
>=65 years
34
  30.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
Female
100
  89.3%
Male
12
  10.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 112 participants
Asian
27
  24.1%
Black
17
  15.2%
Caucasian
61
  54.5%
American Indian
1
   0.9%
Other
2
   1.8%
Unknown
4
   3.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
United States 95
Japan 25
BMI  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 112 participants
26.9
(23.4 to 32)
1.Primary Outcome
Title Number of Participants With Raymond Class I Complete Obliteration at 12 Months
Hide Description Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004).
Time Frame At 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 109
Measure Type: Count of Participants
Unit of Measure: Participants
98
  89.9%
2.Primary Outcome
Title Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.
Hide Description [Not Specified]
Time Frame At 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
3
   2.7%
3.Secondary Outcome
Title Number of Ipsilateral Ischemic Strokes
Hide Description 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
Time Frame At 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: participants
8
4.Secondary Outcome
Title Number of Participants With Device-related Serious Adverse Events
Hide Description 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.
Time Frame During the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
17
  15.2%
5.Secondary Outcome
Title Number of Device Deployment Failures
Hide Description Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm
Time Frame During the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
5
   4.5%
6.Secondary Outcome
Title Number of Device Migrations
Hide Description 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.
Time Frame 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 105
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Aneurysm Raymond Class I Occlusion Grading
Hide Description Raymond Class I Occlusion grading defined as complete obliteration of the aneurysm at 12 months.
Time Frame At 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 109
Measure Type: Count of Participants
Unit of Measure: Participants
99
  90.8%
8.Secondary Outcome
Title Number of Intracranial Hemorrhages
Hide Description 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.
Time Frame At 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.8%
9.Secondary Outcome
Title Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2
Hide Description 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.
Time Frame At 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
106
  99.1%
10.Secondary Outcome
Title All Cause Mortality (Number of Deaths From Any Cause)
Hide Description [Not Specified]
Time Frame At 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
11.Secondary Outcome
Title Number of Retreatments
Hide Description Defined as any intervention after the completion of the initial stent assisted coiling procedure
Time Frame At 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
4
   3.6%
12.Secondary Outcome
Title Number of Participants Who Experienced Device Patency
Hide Description Device patency (stenosis) at 12 months
Time Frame at 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 105
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.9%
13.Secondary Outcome
Title Number of Participants Who Experienced Aneurysm Recanalization
Hide Description [Not Specified]
Time Frame At 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
6
   5.4%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liberty Stent Arm
Hide Arm/Group Description

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
Liberty Stent Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Liberty Stent Arm
Affected / at Risk (%)
Total   34/112 (30.36%) 
Blood and lymphatic system disorders   
Blood and Lymphatic System Disorders   2/112 (1.79%) 
Cardiac disorders   
Cardiac Disorders   3/112 (2.68%) 
Eye disorders   
Eye Disorders   2/112 (1.79%) 
Gastrointestinal disorders   
Gastrointestinal Disorders   6/112 (5.36%) 
General disorders   
General Disorders   6/112 (5.36%) 
Hepatobiliary disorders   
Hepatobiliary Disorders   1/112 (0.89%) 
Infections and infestations   
Infections and Infestations   7/112 (6.25%) 
Injury, poisoning and procedural complications   
Injury, Poisoning and Procedural Complications   3/112 (2.68%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal and connective tissue disorders   1/112 (0.89%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms, benign, malignant and unspecified   2/112 (1.79%) 
Nervous system disorders   
Nervous System Disorders   19/112 (16.96%) 
Psychiatric disorders   
Psychiatric Disorders   1/112 (0.89%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory, Thoracic, and mediastinal disorders   1/112 (0.89%) 
Vascular disorders   
Vascular Disorders   2/112 (1.79%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liberty Stent Arm
Affected / at Risk (%)
Total   96/112 (85.71%) 
Blood and lymphatic system disorders   
Blood and lymphatic system disorders   6/112 (5.36%) 
Cardiac disorders   
Cardiac disorders   6/112 (5.36%) 
Ear and labyrinth disorders   
Ear and labyrinth disorders   4/112 (3.57%) 
Endocrine disorders   
Endrocrine disorders   1/112 (0.89%) 
Eye disorders   
Eye Disorders   34/112 (30.36%) 
General disorders   
General Disorders   23/112 (20.54%) 
Immune system disorders   
Immune System Disorders   6/112 (5.36%) 
Infections and infestations   
Infections and Infestations   22/112 (19.64%) 
Injury, poisoning and procedural complications   
Injury, poisoning, and procedural complications   11/112 (9.82%) 
Investigations   
Investigations   2/112 (1.79%) 
Metabolism and nutrition disorders   
Metabolism and nutrition disorders   6/112 (5.36%) 
Musculoskeletal and connective tissue disorders   
Muskuloskeletal and connective tissue disorders   10/112 (8.93%) 
Nervous system disorders   
Nervous System Disorders   60/112 (53.57%) 
Psychiatric disorders   
Psychiatric Disorders   1/112 (0.89%) 
Renal and urinary disorders   
Renal and urinary disorders   6/112 (5.36%) 
Reproductive system and breast disorders   
Reproductive system and breast disorders   2/112 (1.79%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders   9/112 (8.04%) 
Skin and subcutaneous tissue disorders   
Skin and subcutaneous tissue disorders   12/112 (10.71%) 
Surgical and medical procedures   
Surgical and Medical Procedures   1/112 (0.89%) 
Vascular disorders   
Vascular Disorders   15/112 (13.39%) 
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Michaella Corso
Organization: Penumbra, Inc.
Phone: (510) 748-3200
Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT01636453     History of Changes
Other Study ID Numbers: CLP 5038 (IDE # G120050)
First Submitted: July 2, 2012
First Posted: July 10, 2012
Results First Submitted: April 10, 2018
Results First Posted: August 23, 2018
Last Update Posted: August 23, 2018