Intracranial Bifurcating Aneurysms
Conditions
Brief summary
Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms in the middle cerebral and basilar arteries.
Interventions
DEVICEBARREL VRD
The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Sponsors
Medtronic Neurovascular Clinical Affairs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female between 18 and 85 years old. 2. A wide-neck de novo or non-de novo aneurysm. 3. Appropriate informed consent obtainable as determined by local IRB. 4. Life expectancy \> 24 months.
Exclusion criteria
1. Aneurysm rupture within 30 days of enrollment. 2. Bifurcating aneurysms not treatable with coiling. 3. Subject has platelet count of \<70,000. 4. Subject has known allergies to nickel-titanium metal. 5. Subject has known allergies to aspirin or heparin. 6. Subject has a life-threatening allergy to contrast (unless treatment for allergy can be tolerated). 7. Subject is currently participating in another clinical research study. 8. Subject is pregnant or breastfeeding. 9. Subject has participated in a drug study within the last 30 days. 10. Subject is unable or unwilling to comply with protocol requirements and obtain required clinical evaluations and follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture | 12 months, after device implant | The primary effectiveness endpoint was the count of participants achieving Raymond Grade I (100% occlusion) of the aneurysm treated with the Barrel VRD at 12 months ± 8 weeks in the absence of retreatment, parent artery stenosis (\>50%), or target aneurysm rupture The Raymond Grade Classification definitions evaluated by an independent core laboratory are as follows: Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac. Class 3: Residual aneurysm - opacification of the aneurysmal sac |
| Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period. | 12 months, after device implant | The primary safety endpoint was the number of participants reported with a neurological death or major ipsilateral stroke (National Institute of Stroke Scale (NIHSS) increase of ≥ 4 for \> 24 hours) at any time during the follow-up period. The NIHSS is a tool used to quantify neurological impairment caused by stroke. The scale interpretation is as follows: 0: No stroke symptoms 1-4: Minor stroke symptoms 5-15: Moderate stroke 16-20: Moderate to severe stroke 21-42: Severe strokeThe National Institutes of Health Stroke Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Raymond Grade I (100% Complete Occlusion) and Raymond Grade II (Residual Neck) for Participants Treated With the Barrel VRD, in the Absence of Retreatment, Parent Artery Stenosis (>50%), or Target Aneurysm Rupture at 12 Months | 12 months, after device implant | This secondary outcome measure provides the count of participants treated with the Barrel VRD with Independent Core Laboratory aneurysm occlusion imaging evaluations of Complete Occlusion (Raymond Grade I) and Residual Aneurysm Neck (Raymond Grade II) at 12 months combined. Subjects with evidence of parent artery stenosis, retreatment, or rupture were not considered success. Raymond Grade Scale Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac. Class 3: Residual aneurysm - opacification of the aneurysmal sac. |
| Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline | 12 months, after device implant | This secondary outcome provides the count of participants treated with the Barrel device with a Modified Rankin Score of 0-2 at 12 months or no change from baseline. The Modified Rankin Score is a scale for measuring general functionality as follows: 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 assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead |
| Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks | 30 Days and 12 months +/- 8 weeks | This secondary outcome measure provides the combined number and percentage of subjects that died within 30 days or had a neurologic death within 12 months of receiving the study device. |
| Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% | At 12 Months +/- 8 weeks | This secondary measure provides the count of participants with parent artery stenosis per an independent core lab evaluation within the following ordinal groups: \<25%, 25-50%, 51-75%, \>75%. |
| Number of Participants With Successfully Deployed Barrel VRD | Index Procedure, Day 0 | This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reported Device Related Serious Adverse Events | From the point of consent until participant exits the study at 1 year | This secondary outcome measure provides the count of participants reported with a Serious Device Related Adverse Events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BARREL VRD The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. | 127 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Enrollment | Exit Prior to Device Attempt | 11 |
| Follow-Up Post Barrel VRD Implanted | Death | 3 |
| Follow-Up Post Barrel VRD Implanted | Lost to Follow-up | 1 |
| Follow-Up Post Barrel VRD Implanted | Physician Decision | 2 |
| Follow-Up Post Barrel VRD Implanted | Withdrawal by Subject | 3 |
| Index Procedure With Barrel VRD Attempt | Did not receive Barrel VRD | 7 |
Baseline characteristics
| Characteristic | BARREL VRD |
|---|---|
| Age, Continuous Mean ± Standard Deviation | 60.4 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 108 Participants |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 127 |
| other Total, other adverse events | 73 / 127 |
| serious Total, serious adverse events | 44 / 127 |
Outcome results
Primary
Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period.
The primary safety endpoint was the number of participants reported with a neurological death or major ipsilateral stroke (National Institute of Stroke Scale (NIHSS) increase of ≥ 4 for \> 24 hours) at any time during the follow-up period. The NIHSS is a tool used to quantify neurological impairment caused by stroke. The scale interpretation is as follows: 0: No stroke symptoms 1-4: Minor stroke symptoms 5-15: Moderate stroke 16-20: Moderate to severe stroke 21-42: Severe strokeThe National Institutes of Health Stroke Scale
Time frame: 12 months, after device implant
Population: Participants implanted with the Barrel VRD
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BARREL VRD | Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period. | 5 Participants |
Primary
Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture
The primary effectiveness endpoint was the count of participants achieving Raymond Grade I (100% occlusion) of the aneurysm treated with the Barrel VRD at 12 months ± 8 weeks in the absence of retreatment, parent artery stenosis (\>50%), or target aneurysm rupture The Raymond Grade Classification definitions evaluated by an independent core laboratory are as follows: Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac. Class 3: Residual aneurysm - opacification of the aneurysmal sac
Time frame: 12 months, after device implant
Population: Subjects treated with the Barrel VRD that completed the 12 month visit imaging
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BARREL VRD | Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture | 67 Participants |
Secondary
Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75%
This secondary measure provides the count of participants with parent artery stenosis per an independent core lab evaluation within the following ordinal groups: \<25%, 25-50%, 51-75%, \>75%.
Time frame: At 12 Months +/- 8 weeks
Population: Outcomes are based on observed data on 89 participants with evaluable angiographic data at 1 year. 38/127 participants did not have angiographic data at 1 year available for analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BARREL VRD | Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% | In-Stent Stenosis at 12 Months < 25% | 88 Participants |
| BARREL VRD | Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% | In-Stent Stenosis at 12 Months 25-50% | 1 Participants |
| BARREL VRD | Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% | In-Stent Stenosis at 12 Months 51-75% | 0 Participants |
| BARREL VRD | Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% | In-Stent Stenosis at 12 Months < 75% | 0 Participants |
Secondary
Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks
This secondary outcome measure provides the combined number and percentage of subjects that died within 30 days or had a neurologic death within 12 months of receiving the study device.
Time frame: 30 Days and 12 months +/- 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BARREL VRD | Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks | 1 Participants |
Secondary
Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline
This secondary outcome provides the count of participants treated with the Barrel device with a Modified Rankin Score of 0-2 at 12 months or no change from baseline. The Modified Rankin Score is a scale for measuring general functionality as follows: 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 assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Time frame: 12 months, after device implant
Population: Outcomes are based on observed data, from 111 participants completed at 1-year and 3 participants with an mRS score of 6 (death) prior to 1 year.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BARREL VRD | Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline | 107 Participants |
Secondary
Number of Participants With Raymond Grade I (100% Complete Occlusion) and Raymond Grade II (Residual Neck) for Participants Treated With the Barrel VRD, in the Absence of Retreatment, Parent Artery Stenosis (>50%), or Target Aneurysm Rupture at 12 Months
This secondary outcome measure provides the count of participants treated with the Barrel VRD with Independent Core Laboratory aneurysm occlusion imaging evaluations of Complete Occlusion (Raymond Grade I) and Residual Aneurysm Neck (Raymond Grade II) at 12 months combined. Subjects with evidence of parent artery stenosis, retreatment, or rupture were not considered success. Raymond Grade Scale Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac. Class 3: Residual aneurysm - opacification of the aneurysmal sac.
Time frame: 12 months, after device implant
Population: Outcomes are based on observed data (i.e., 106 participants with 12-month evaluable imaging). 21/127 participants did not have evaluable imaging at 1-Year.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BARREL VRD | Number of Participants With Raymond Grade I (100% Complete Occlusion) and Raymond Grade II (Residual Neck) for Participants Treated With the Barrel VRD, in the Absence of Retreatment, Parent Artery Stenosis (>50%), or Target Aneurysm Rupture at 12 Months | 75 Participants |
Secondary
Number of Participants With Successfully Deployed Barrel VRD
This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD.
Time frame: Index Procedure, Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BARREL VRD | Number of Participants With Successfully Deployed Barrel VRD | 120 Participants |
Other Pre-specified
Number of Participants With Reported Device Related Serious Adverse Events
This secondary outcome measure provides the count of participants reported with a Serious Device Related Adverse Events
Time frame: From the point of consent until participant exits the study at 1 year
Population: Subjects with an Attempted Barrel VRD Implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BARREL VRD | Number of Participants With Reported Device Related Serious Adverse Events | 4 Participants |