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Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms

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ClinicalTrials.gov Identifier: NCT02179190
Recruitment Status : Completed
First Posted : July 1, 2014
Results First Posted : December 5, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Intracranial Bifurcating Aneurysms
Intervention Device: BARREL VRD
Enrollment 138
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BARREL VRD
Hide Arm/Group Description 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.
Period Title: Enrollment
Started [1] 138
Completed [2] 127
Not Completed 11
Reason Not Completed
Exit Prior to Device Attempt             11
[1]
Participants Consented and Assessed for Eligibility
[2]
Attempted with the Study Device - Intent to Treat Population
Period Title: Index Procedure With Barrel VRD Attempt
Started [1] 127
Completed [2] 120
Not Completed 7
Reason Not Completed
Did not receive Barrel VRD             7
[1]
Participants with an attempted Barrel VRD Implant
[2]
Participants with a Successful Barrel Implant
Period Title: Follow-Up Post Barrel VRD Implanted
Started [1] 120
Completed [2] 111
Not Completed 9
Reason Not Completed
Death             3
Withdrawal by Subject             3
Physician Decision             2
Lost to Follow-up             1
[1]
Participants Implanted with the Barrel VRD Expected to Complete the 12 Month Visit
[2]
Participants Implanted with the Barrel VRD that Completed the 12 Month Visit
Arm/Group Title BARREL VRD
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 127
Hide Baseline Analysis Population Description
Participants with enrolled (consented ) with an attempted Barrel VRD Implant
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean ± Standard Deviation Number Analyzed 127 participants
60.4  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants
Female
91
  71.7%
Male
36
  28.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants
Hispanic or Latino
12
   9.4%
Not Hispanic or Latino
108
  85.0%
Unknown or Not Reported
7
   5.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
12
   9.4%
White
108
  85.0%
More than one race NA [1] 
Unknown or Not Reported
2
   1.6%
[1]
Subjects with more than one race were not collected
1.Primary Outcome
Title Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants implanted with the Barrel VRD
Arm/Group Title BARREL VRD
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 127
Measure Type: Count of Participants
Unit of Measure: Participants
5
   3.9%
2.Primary Outcome
Title 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
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects treated with the Barrel VRD that completed the 12 month visit imaging
Arm/Group Title BARREL VRD
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 106
Measure Type: Count of Participants
Unit of Measure: Participants
67
  63.2%
3.Secondary Outcome
Title Number of Participants With Successfully Deployed Barrel VRD
Hide Description This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD.
Time Frame Index Procedure, Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BARREL VRD
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 127
Measure Type: Count of Participants
Unit of Measure: Participants
120
  94.5%
4.Secondary Outcome
Title 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
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title BARREL VRD
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 106
Measure Type: Count of Participants
Unit of Measure: Participants
75
  70.8%
5.Secondary Outcome
Title Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title BARREL VRD
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 114
Measure Type: Count of Participants
Unit of Measure: Participants
107
  93.9%
6.Secondary Outcome
Title 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%
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title BARREL VRD
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 89
Measure Type: Count of Participants
Unit of Measure: Participants
In-Stent Stenosis at 12 Months < 25%
88
  98.9%
In-Stent Stenosis at 12 Months 25-50%
1
   1.1%
In-Stent Stenosis at 12 Months 51-75%
0
   0.0%
In-Stent Stenosis at 12 Months < 75%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BARREL VRD
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 127
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.8%
8.Other Pre-specified Outcome
Title Number of Participants With Reported Device Related Serious Adverse Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with an Attempted Barrel VRD Implant
Arm/Group Title BARREL VRD
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 127
Measure Type: Count of Participants
Unit of Measure: Participants
4
   3.1%
Time Frame Adverse Events were collected from the point of consent through the study exit at 12 months.
Adverse Event Reporting Description

The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria:

  • Neurological cause adverse events with a corresponding worsening of NIHSS,
  • All Device related adverse events,
  • All Procedure related adverse events,
  • All SAEs, and
  • All Antiplatelet therapy related events.
 
Arm/Group Title BARREL VRD
Hide Arm/Group Description 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.
All-Cause Mortality
BARREL VRD
Affected / at Risk (%)
Total   3/127 (2.36%)    
Show Serious Adverse Events Hide Serious Adverse Events
BARREL VRD
Affected / at Risk (%) # Events
Total   44/127 (34.65%)    
Blood and lymphatic system disorders   
Anaemia * 1  4/127 (3.15%)  4
Cardiac disorders   
Acute myocardial infarction * 1  2/127 (1.57%)  2
Atrial fibrillation * 1  1/127 (0.79%)  1
Atrioventricular block complete * 1  1/127 (0.79%)  1
Cardiac failure congestive * 1  2/127 (1.57%)  2
Cardio-respiratory arrest * 1  1/127 (0.79%)  1
Cardiopulmonary failure * 1  1/127 (0.79%)  1
Coronary artery disease * 1  1/127 (0.79%)  1
Myocardial ischaemia * 1  1/127 (0.79%)  1
Gastrointestinal disorders   
Duodenal ulcer haemorrhage * 1  1/127 (0.79%)  1
Gastrointestinal haemorrhage * 1  1/127 (0.79%)  1
Haematochezia * 1  1/127 (0.79%)  1
Impaired gastric emptying * 1  1/127 (0.79%)  1
Retroperitoneal haemorrhage * 1  2/127 (1.57%)  2
General disorders   
Adverse drug reaction * 1  1/127 (0.79%)  1
Catheter site haematoma * 1  2/127 (1.57%)  2
Infections and infestations   
Pneumonia bacterial * 1  1/127 (0.79%)  1
Pneumonia * 1  2/127 (1.57%)  2
Urinary tract infection * 1  3/127 (2.36%)  3
Injury, poisoning and procedural complications   
Traumatic intracranial haemorrhage * 1  1/127 (0.79%)  1
Metabolism and nutrition disorders   
Hypernatraemia * 1  1/127 (0.79%)  1
Hyponatraemia * 1  1/127 (0.79%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/127 (0.79%)  1
Neck Pain * 1  1/127 (0.79%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Glioma * 1  1/127 (0.79%)  1
Lung adenocarcinoma * 1  1/127 (0.79%)  1
Lung cancer metastatic * 1  1/127 (0.79%)  1
Retroperitoneal cancer * 1  1/127 (0.79%)  1
Nervous system disorders   
Brain oedema * 1  1/127 (0.79%)  1
Carotid artery stenosis * 1  1/127 (0.79%)  1
Cerebral infarction * 1  2/127 (1.57%)  2
Convulsion * 1  2/127 (1.57%)  2
Haemorrhage intracranial * 1  1/127 (0.79%)  1
Hemiparesis * 1  1/127 (0.79%)  2
Hydrocephalus * 1  1/127 (0.79%)  1
Ischaemic stroke * 1  8/127 (6.30%)  8
Migraine * 1  1/127 (0.79%)  1
Status epilepticus * 1  1/127 (0.79%)  1
Transient ischaemic attack * 1  1/127 (0.79%)  1
Vertebral artery dissection * 1  1/127 (0.79%)  1
Psychiatric disorders   
Mental status changes * 1  1/127 (0.79%)  1
Renal and urinary disorders   
Glomerulonephritis rapidly progressive * 1  1/127 (0.79%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure * 1  3/127 (2.36%)  3
Chronic obstructive pulmonary disease * 1  2/127 (1.57%)  4
Pneumonia aspiration * 1  2/127 (1.57%)  2
Pulmonary embolism * 1  1/127 (0.79%)  1
Respiratory failure * 1  1/127 (0.79%)  1
Surgical and medical procedures   
Spinal decompression * 1  1/127 (0.79%)  1
Vascular disorders   
Aneurysm * 1  1/127 (0.79%)  1
Hypertensive emergency * 1  1/127 (0.79%)  1
1
Term from vocabulary, MedDRA (17.1)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BARREL VRD
Affected / at Risk (%) # Events
Total   73/127 (57.48%)    
Cardiac disorders   
Palpitations * 1  1/127 (0.79%)  1
Ear and labyrinth disorders   
Tinnitus * 1  1/127 (0.79%)  1
Eye disorders   
Diplopia * 1  1/127 (0.79%)  1
Eyelid ptosis * 1  2/127 (1.57%)  2
Photopsia * 1  1/127 (0.79%)  1
Vision blurred * 1  3/127 (2.36%)  4
Visual impairment * 1  3/127 (2.36%)  3
Gastrointestinal disorders   
Colitis * 1  1/127 (0.79%)  1
Gastrointestinal haemorrhage * 1  3/127 (2.36%)  3
Nausea * 1  9/127 (7.09%)  9
Oral mucosal blistering * 1  1/127 (0.79%)  1
Rectal haemorrhage * 1  1/127 (0.79%)  1
Upper gastrointestinal haemorrhage * 1  1/127 (0.79%)  1
Vomiting * 1  1/127 (0.79%)  1
General disorders   
Catheter site haemorrhage * 1  7/127 (5.51%)  7
Asthenia * 1  1/127 (0.79%)  1
Catheter site haematoma * 1  5/127 (3.94%)  5
Catheter site inflammation * 1  1/127 (0.79%)  1
Catheter site swelling * 1  1/127 (0.79%)  1
Chest pain * 1  2/127 (1.57%)  2
Drug intolerance * 1  1/127 (0.79%)  1
Fatigue * 1  1/127 (0.79%)  1
Injection site haemorrhage * 1  1/127 (0.79%)  1
Local swelling * 1  1/127 (0.79%)  1
Thrombosis in device * 1  2/127 (1.57%)  2
Infections and infestations   
Urinary tract infection * 1  2/127 (1.57%)  2
Injury, poisoning and procedural complications   
Anaemia postoperative * 1  1/127 (0.79%)  1
Ankle fracture * 1  1/127 (0.79%)  1
Joint injury * 1  1/127 (0.79%)  1
Procedural hypertension * 1  1/127 (0.79%)  1
Procedural hypotension * 1  1/127 (0.79%)  1
Procedural pain * 1  1/127 (0.79%)  1
Radiation skin injury * 1  1/127 (0.79%)  1
Wound secretion * 1  1/127 (0.79%)  1
Metabolism and nutrition disorders   
Electrolyte imbalance * 1  1/127 (0.79%)  1
Fluid overload * 1  1/127 (0.79%)  1
Glucose tolerance impaired * 1  1/127 (0.79%)  1
Musculoskeletal and connective tissue disorders   
Arthritis * 1  1/127 (0.79%)  1
Groin pain * 1  2/127 (1.57%)  2
Joint effusion * 1  1/127 (0.79%)  1
Muscle spasms * 1  1/127 (0.79%)  1
Muscular weakness * 1  2/127 (1.57%)  2
Nervous system disorders   
Headache * 1  24/127 (18.90%)  27
Amnesia * 1  1/127 (0.79%)  1
Aphasia * 1  1/127 (0.79%)  1
Balance disorder * 1  1/127 (0.79%)  1
Cerebral artery thrombosis * 1  2/127 (1.57%)  2
Cerebral infarction * 1  1/127 (0.79%)  1
Dizziness * 1  7/127 (5.51%)  8
Hypoaesthesia * 1  2/127 (1.57%)  3
Migraine * 1  1/127 (0.79%)  1
Paraesthesia * 1  2/127 (1.57%)  2
Spondylitic myelopathy * 1  1/127 (0.79%)  1
Syncope * 1  1/127 (0.79%)  1
Transient ischaemic attack * 1  3/127 (2.36%)  4
Tremor * 1  1/127 (0.79%)  1
Psychiatric disorders   
Disorientation * 1  1/127 (0.79%)  1
Renal and urinary disorders   
Haematuria * 1  1/127 (0.79%)  1
Urethral pain * 1  1/127 (0.79%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  7/127 (5.51%)  7
Dyspnoea * 1  1/127 (0.79%)  1
Skin and subcutaneous tissue disorders   
Ecchymosis * 1  9/127 (7.09%)  10
Alopecia * 1  1/127 (0.79%)  1
Surgical and medical procedures   
Aneurysm repair * 1  1/127 (0.79%)  1
Vascular disorders   
Aneurysm * 1  1/127 (0.79%)  1
Arterial stenosis * 1  3/127 (2.36%)  3
Intermittent claudication * 1  1/127 (0.79%)  1
Thrombophlebitis * 1  1/127 (0.79%)  1
Vasospasm * 1  1/127 (0.79%)  1
1
Term from vocabulary, MedDRA (17.1)
*
Indicates events were collected by non-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: Senior Manager, Clinical Project Management
Organization: Medtronic Plc
Phone: 949-680-1274
Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02179190     History of Changes
Other Study ID Numbers: VRD-001
First Submitted: June 27, 2014
First Posted: July 1, 2014
Results First Submitted: October 25, 2018
Results First Posted: December 5, 2018
Last Update Posted: December 25, 2018