Trial Outcomes & Findings for Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device (NCT NCT02532517)
NCT ID: NCT02532517
Last Updated: 2020-10-23
Results Overview
The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. RCAO was assessed by the Independent Core Laboratory, complete aneurysm occlusion is defined as an aneurysm in which a Grade I (completion occlusion), is achieved on the Raymond Scale at the relevant post-procedure angiogram, without additional procedures for treatment of the aneurysm since the index procedure. Participants who were retreated (retreatment includes staged procedures) prior to the 12-month were considered not to have achieved complete aneurysm occlusion.
TERMINATED
NA
45 participants
12 Months Post Procedure
2020-10-23
Participant Flow
Participant milestones
| Measure |
CODMAN ENTERPRISE
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
mITT Analysis Set
|
44
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
CODMAN ENTERPRISE
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Overall Study
Did not complete 24-Month visit
|
4
|
|
Overall Study
Failed Angiographic eligibility
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Death
|
4
|
Baseline Characteristics
Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device
Baseline characteristics by cohort
| Measure |
CODMAN ENTERPRISE
n=44 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 12.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 Months Post ProcedurePopulation: Modified Intent to Treat (mITT) analysis set: participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted. Here 'N' (Number of participants analyzed) included all participants available at 12-month visit with non missing values for this outcome measure (OM).
The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. RCAO was assessed by the Independent Core Laboratory, complete aneurysm occlusion is defined as an aneurysm in which a Grade I (completion occlusion), is achieved on the Raymond Scale at the relevant post-procedure angiogram, without additional procedures for treatment of the aneurysm since the index procedure. Participants who were retreated (retreatment includes staged procedures) prior to the 12-month were considered not to have achieved complete aneurysm occlusion.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=22 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Percentage of Participants With Complete Aneurysm Occlusion (RCAO) Without Retreatment at 12-Month Post Procedure
|
81.8 Percentage of Participants
Interval 59.7 to 94.8
|
PRIMARY outcome
Timeframe: At 12 Months Post ProcedurePopulation: mITT analysis set defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted. Here 'N' (Number of participants analyzed) signifies participants who have been followed-up to the timepoint of interest (12 months) in the population for this OM.
The incidence of a major ipsilateral stroke and/or death due to ipsilateral stroke was evaluated from the start of the index procedure until completion of the 12-month follow-up. A major ipsilateral stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of greater than or equal to (\>=) 4 on the National Institute of Health Stroke Scale (NIHSS) as compared to baseline and persists for greater than 24 hours. The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of 0 indicates no stroke; 1-4 as minor stroke; 5-15 as moderate stroke; 15-20 as moderate/severe stroke; 21-42 as severe stroke. NIHSS worsening is defined as an increase from baseline of \>= 4.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=40 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Percentage of Participants With Major Ipsilateral Stroke and/or Death Due to Ipsilateral Stroke at 12 Months Post Procedure
Ipsilateral Stroke
|
7.5 Percentage of participants
Interval 1.6 to 20.4
|
|
Percentage of Participants With Major Ipsilateral Stroke and/or Death Due to Ipsilateral Stroke at 12 Months Post Procedure
Death related to Ipsilateral Stroke
|
0 Percentage of participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: At 12 Months post procedurePopulation: mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted. Here 'N' (Number of participants analyzed) signifies all participants who were available at the 12-month visit with non-missing values for this OM.
In-stent stenosis is defined as greater than 50 percent (%) narrowing of the vessel within the ENTERPRISE stent or within 10 millimeters (mm) of either end of the stent.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=23 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Percentage of Participant With In-Stent Stenosis at 12 Months Post Procedure Per Independent Core Laboratory
|
0.0 Percentage of participants
Interval 0.0 to 14.8
|
SECONDARY outcome
Timeframe: Immediately post-procedure (acute), 6 and 12 monthsPopulation: mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted. Here 'n' (number analyzed) signifies participants available at specified visits with non-missing values of the OM.
The procedure success rate is defined to be the percentage of aneurysms in which coil mass position is maintained within the sac with parent artery patency, without additional procedures for treatment of the aneurysm since the index procedure. The procedure success was summarized immediately post-treatment (acute), and at the 6- and 12-month follow-up assessments.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=44 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants With Procedure Success Immediately Post-procedure (Acute), 6 and 12 Months
Immediately post-procedure (acute)
|
41 Participants
|
|
Number of Participants With Procedure Success Immediately Post-procedure (Acute), 6 and 12 Months
6-Month Follow-up
|
34 Participants
|
|
Number of Participants With Procedure Success Immediately Post-procedure (Acute), 6 and 12 Months
12-Month Follow-up
|
23 Participants
|
SECONDARY outcome
Timeframe: Immediately post-procedure (acute), 6 and 12 monthsPopulation: mITT analysis set included. Here 'N' (Number of participants analyzed) signifies all evaluable participants with valid assessments post procedure for this OM and 'n' (number analyzed) signifies participants available at the schedule visits with non-missing values of the OM.
The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. RCAO was assessed by the Independent Core Laboratory, complete aneurysm occlusion is defined as an aneurysm in which a Grade I (completion occlusion), is achieved on the Raymond Scale at the relevant post-procedure angiogram, without additional procedures for treatment of the aneurysm since the index procedure. Participants who are retreated (retreatment includes staged procedures) prior to the 12-month were considered not to have achieved complete aneurysm occlusion.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=42 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants With Complete Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
Immediately post-procedure (acute)
|
16 Participants
|
|
Number of Participants With Complete Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
6-Month Follow Up
|
24 Participants
|
|
Number of Participants With Complete Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
12-Month Follow Up
|
18 Participants
|
SECONDARY outcome
Timeframe: Immediately post-procedure (acute), 6 and 12 MonthsPopulation: mITT analysis set included. Here 'N' (Number of participants analyzed) signifies all evaluable participants with valid assessments post procedure for this OM and 'n' (number analyzed) signifies number of participants available at the specified visits with non-missing values of the OM.
The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. Complete/partial aneurysm occlusion is defined as an aneurysm in which a score of 1 (complete occlusion) or 2 (residual neck) is achieved on the Raymond Scale, regardless of retreatment. Participants who are retreated (retreatment includes staged procedures) prior to the 12-month post-procedure follow-up visit was considered not to have achieved complete aneurysm occlusion.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=42 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants With Complete/Partial Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
Immediately post-procedure (acute)
|
34 Participants
|
|
Number of Participants With Complete/Partial Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
6-Month Follow Up
|
32 Participants
|
|
Number of Participants With Complete/Partial Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
12-Month Follow Up
|
21 Participants
|
SECONDARY outcome
Timeframe: Immediately post-procedure (acute), 6 and 12 monthsPopulation: mITT analysis set included. Here 'N' (Number of participants analyzed) signifies all evaluable participants with valid assessments post procedure for this OM and 'n' (number analyzed) signifies number of participants available at the specified visits with non-missing values of the OM.
Number of Participants with aneurysms occlusion of 100%, 90%-99%, 70-89%, 50-69%, 25-49%, or \<25% occlusion in accordance with Consensus Grades 0 (100% complete aneurysm occlusion) - 5 (\<25% volumetric aneurysm occlusion), respectively, was reported immediately post-procedure (acute), and at the 6 and 12 month follow-up, respectively.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=42 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
Immediately post-procedure (acute) · 100%
|
16 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
Immediately post-procedure (acute) · 90% - 99%
|
26 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
Immediately post-procedure (acute) · 70% - 89%
|
0 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
Immediately post-procedure (acute) · 50% - 69%
|
0 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
Immediately post-procedure (acute) · 25% - 49%
|
0 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
Immediately post-procedure (acute) · <25%
|
0 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
6-Month Follow-up · 100%
|
24 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
6-Month Follow-up · 90% - 99%
|
8 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
6-Month Follow-up · 70% - 89%
|
2 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
6-Month Follow-up · 50% - 69%
|
0 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
6-Month Follow-up · 25% - 49%
|
0 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
6-Month Follow-up · <25%
|
0 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
12-Month Follow-up · 100%
|
18 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
12-Month Follow-up · 90% - 99%
|
3 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
12-Month Follow-up · 70% - 89%
|
1 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
12-Month Follow-up · 50% - 69%
|
0 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
12-Month Follow-up · 25% - 49%
|
0 Participants
|
|
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
12-Month Follow-up · <25%
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted. Here 'N' (number of participants analyzed) included all evaluable participants with data available for this OM.
Number of participants with aneurysm recanalization was reported. Recanalization was defined as an increase in aneurysm filling as compared to the previous study-specified angiographic assessment, resulting in a change in (that is, worsening of) the Raymond classification.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=23 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants With Aneurysm Recanalization
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: mITT analysis set: participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted. Here 'N' (number of participants analyzed) included participants who had been followed up to 12-month follow-up, or otherwise who were retreated prior to 12-Month Follow-up.
Retreatment was defined as any additional treatment of the target aneurysm after the index procedure (retreatment includes staged procedures), or an additional procedure (regardless of whether retreatment is by surgery or endovascular treatment) due to recanalization, rupture or bleeding.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=37 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants Retreated With Any Additional Treatment
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-procedure up to 30-Day, 6-Month Follow-up and 12-Month Follow-upPopulation: mITT analysis set: participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted. Here 'n' (number analyzed) signifies number of participants available at the specified visits with non-missing values of the OM.
Observed scores on the Modified Ranking Scale was presented at baseline (pre-procedure) and follow-up (30 days, 6 and 12 months post-procedure). mRS score: 0 = no symptoms at all; 1 = no significant disability despite symptoms, able to carry out all usual duties and activities; 2 = slight disability, unable to carry out all previous activities but able to look after own affairs without assistant; 3 = moderate disability, requires some help, but able to walk without assistance; 4 = moderate to severe disability, unable to walk without assistance, and unable to attend own bodily needs without assistance; 5 = severe disability, bedridden, incontinent, and requiring constant nursing care and attention; 6 = dead. The number of participants who had an increase in mRS \> 2 from baseline not related to stroke or death was also be presented for each follow-up time point.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=44 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants With New Neurological Deficits as Per the Modified Rankin Scale (mRS) Score
Post-procedure up to 30-Day Follow-up
|
5 Participants
|
|
Number of Participants With New Neurological Deficits as Per the Modified Rankin Scale (mRS) Score
Post-procedure up to 6-Month Follow-up
|
5 Participants
|
|
Number of Participants With New Neurological Deficits as Per the Modified Rankin Scale (mRS) Score
Post-procedure up to 12-Month Follow-up
|
5 Participants
|
SECONDARY outcome
Timeframe: Post-procedure up to 6-Month and 12-Month Follow-upPopulation: mITT analysis set included. Here 'N' (Number of participants analyzed) included participants who had at least one post-baseline NIHSS scores and 'n' (number analyzed) signifies number of participants analyzed at specified time points.
The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of 0 indicates no stroke; 1-4 as minor stroke; 5-15 as moderate stroke; 15-20 as moderate/severe stroke; 21-42 as severe stroke. NIHSS worsening is defined as an increase from baseline of \>= 4.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=38 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants With NIH Stroke Scale (NIHSS) Worsening
Post-procedure up to 6-Month Follow-up
|
2 Participants
|
|
Number of Participants With NIH Stroke Scale (NIHSS) Worsening
Post-procedure up to 12-Month Follow-up
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Intraoperative)Population: mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
The percentage of target aneurysms in which a new occurrence of unintentional and persistent reduced TICI flow (TICI grade of 0: No perfusion or 1: Partial perfusion) was observed at the target vessel during the index procedure as a result of a mechanical obstruction such as dissection or luminal thrombus was evaluated. TICI evaluates perfusion severity and ranges from Grade 0 (No perfusion) to 3 (Complete perfusion).
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=44 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants With Reduced Thrombolysis in Cerebral Infarction (TICI) Flow (New Occurrence of TICI Grade of 0 or 1)
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: mITT analysis set included. Here 'N' (Number of participants analyzed) included all participants with data available for this OM and 'n' (number analyzed) signifies number of participants analyzed at specified time points.
The number of participants who experienced a procedure-related hemorrhagic event which required any of the following was evaluated: blood transfusion, surgical intervention, a new hospitalization, or lengthening of hospital stay. The complications of hematoma requiring treatment (that is, hematoma \> 5 centimeter \[cm\] in diameter occurring at the access site) and retroperitoneal bleeding were reported as hemorrhagic events.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=37 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants With Bleeding Complications
Post-procedure up to 6-Month Follow-up
|
3 Participants
|
|
Number of Participants With Bleeding Complications
Post-procedure up to 12-Month Follow-up
|
3 Participants
|
SECONDARY outcome
Timeframe: During procedure (acute), post-procedure up to 6 months and 12 months follow upPopulation: mITT analysis set included. Here 'N' (Number of participants analyzed) included all participants with data available for this OM and 'n' (number analyzed) signifies number of participants analyzed at specified time points.
In-stent stenosis is defined as greater than 50% narrowing of the vessel within the ENTERPRISE stent or within 10 mm of either end of the stent.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=42 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants With In-Stent Stenosis Per Independent Core Laboratory During Procedure (Acute), Post-procedure up to 6 Months and 12 Months Follow up
During procedure (acute)
|
0 Participants
|
|
Number of Participants With In-Stent Stenosis Per Independent Core Laboratory During Procedure (Acute), Post-procedure up to 6 Months and 12 Months Follow up
Post-procedure up to 6-Month Follow-up
|
0 Participants
|
|
Number of Participants With In-Stent Stenosis Per Independent Core Laboratory During Procedure (Acute), Post-procedure up to 6 Months and 12 Months Follow up
Post-procedure up to 12-Month Follow-up
|
0 Participants
|
SECONDARY outcome
Timeframe: During procedure (acute), post-procedure up to 6 months and 12 months follow upPopulation: mITT analysis set included. Here 'N' (Number of participants analyzed) included all participants with data available for this OM and 'n' (number analyzed) signifies number of participants analyzed at specified time points.
Thrombosis is defined as in-stent thrombosis.
Outcome measures
| Measure |
CODMAN ENTERPRISE
n=42 Participants
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Number of Participants With Thrombosis Per Independent Core Laboratory
During procedure (acute)
|
1 Participants
|
|
Number of Participants With Thrombosis Per Independent Core Laboratory
Post-procedure up to 6-Month Follow-up
|
0 Participants
|
|
Number of Participants With Thrombosis Per Independent Core Laboratory
Post-procedure up to 12-Month Follow-up
|
0 Participants
|
Adverse Events
CODMAN ENTERPRISE
Serious adverse events
| Measure |
CODMAN ENTERPRISE
n=44 participants at risk
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Infections and infestations
Pneumonia
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
2.3%
1/44 • Number of events 2 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
2.3%
1/44 • Number of events 2 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Nervous system disorders
Cerebral artery occlusion
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Nervous system disorders
Cerebral artery thrombosis
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Nervous system disorders
Cerebral haemorrhage
|
6.8%
3/44 • Number of events 3 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Nervous system disorders
Dizziness
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Nervous system disorders
Migraine
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Renal and urinary disorders
Haematuria
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Vascular disorders
Arterial thrombosis
|
2.3%
1/44 • Number of events 1 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
Other adverse events
| Measure |
CODMAN ENTERPRISE
n=44 participants at risk
Participants with an unruptured wide-neck, intracranial saccular anterior circulation aneurysm (less than or equal to \[\<=\] 10 millimeters \[mm\]), arising from a parent vessel with a diameter of greater than or equal to \[\>=\] 2.5 mm and \<= 4 mm, treated with either CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System (ENTERPRISE VRD system) and or CODMAN ENTERPRISE 2 Vascular Reconstruction Device and Delivery System (ENTERPRISE 2 VRD system).
|
|---|---|
|
Nervous system disorders
Headache
|
18.2%
8/44 • Number of events 8 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.8%
3/44 • Number of events 3 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.8%
3/44 • Number of events 3 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Renal and urinary disorders
Urinary retention
|
4.5%
2/44 • Number of events 4 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
6.8%
3/44 • Number of events 3 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
|
Vascular disorders
Vasospasm
|
11.4%
5/44 • Number of events 5 • Up to 24 months
mITT analysis set is defined as participants who were found to be eligible for treatment of ENTEPRISE during pre-procedure angiographic assessment, and in whom treatment is attempted.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor can review results communications prior to public release and can embargo communications regarding trial results that is more than 60 days but less than or equal to 180 days from the time submitted to sponsor for review. No results that contain sponsor confidential information may be released without sponsor prior written consent.
- Publication restrictions are in place
Restriction type: OTHER