Headache, Intracranial Aneurysm, Subarachnoid Hemorrhage
Conditions
Brief summary
The primary objective of this study is to evaluate the effectiveness and safety of robotic-assisted endovascular embolization procedures compared to objective performance criteria for traditional, manual operation based on the scientific literature.
Detailed description
This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls. Subject selection requires a clinical indication for endovascular coil and/or stent-assist coiling embolization of cerebral aneurysms.
Interventions
DEVICERobotic Endovascular Procedure
After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.
Sponsors
Corindus Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 18 years. 2. At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; dome to neck ratio \>1.5 or aneurysm neck width \>4.0 mm. 3. The Investigator deems the procedure appropriate for both manual or robotic-assisted endovascular treatment. 4. The conscious subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion criteria
1. Failure / unwillingness of the subject to provide informed consent, unless the EC has waived informed consent. 2. The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment. 3. Women who are pregnant. 4. Persons under guardianship or curatorship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedural Technical Success. | Measured from the start of the procedure to the end of the procedure. | The primary effectiveness endpoint will be defined as successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual for guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy. |
| Number of Intra- and Peri-procedural Events. | Measured from the start of the procedure through 24 hours or discharge, whichever occurs first. | The primary safety endpoint will be a composite of intra- and periprocedural events, including target aneurysmal rupture, vessel perforation or dissection, and thromboembolic event with neurological decline within 24-hours post- procedure or hospital discharge, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Procedure Time | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. | Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter |
| Fluoroscopy Time | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. | Total fluoroscopy utilized during the procedure as recorded by the Imaging System |
| Patient Radiation Exposure | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. | DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure |
| Contrast Fluid Volume | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. | Total contrast used during the procedure |
| Robotically Navigate Device to the Target Aneurysm | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. | Defined as successful advancement of device to the target aneurysm robotically. |
| Number of Thromboembolic Events | Measured from the start of the procedure through end of the study (180-days following the robotic-assisted procedure). | Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure |
| Devices Used Robotically | Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day | Recorded as successful or unsuccessful in conjunction with the CorPath GRX System |
| Number of Participants With Aneurysm Occlusion | Assessed at 180 Day Follow-up | Angiographic assessment of aneurysm occlusion grade according to the Raymond-Roy Occlusion Classification Scale, parent-vessel compromise, and occlusion durability as assessed from an independent core laboratory. Raymond Roy Occlusion Classification Scale - Minimum:1, Maximum: 3b, Higher score meaning worse outcome. |
| Adverse Events | Measured from the start of the procedure through end of the study. Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will undergo clinical follow-up th | All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized; |
| Robotically Deploy Therapeutic Device Into the Target Aneurysm | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. | Defined as successful deployment of therapeutic device into the target aneurysm robotically |
Countries
Australia, Austria, Canada, France, Spain, Switzerland
Participant flow
Recruitment details
The clinical investigation started with enrollment of first subject on 21 August 2020 and subject recruitment was completed on 21 April 2022. With 10 investigational sites, up to 120 subjects were enrolled in order to achieve at least 108 subjects in the study; each site was initially approved to recruit a maximum of 20 subjects. The total study duration was 24 months: the recruitment phase was 18 months and follow-up continues to 180 days.
Participants by arm
| Arm | Count |
|---|---|
| Robotic Endovascular Procedure Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.
Robotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System. | 117 |
| Total | 117 |
Baseline characteristics
| Characteristic | Robotic Endovascular Procedure | — |
|---|---|---|
| Age, Continuous | 56.6 YEARS STANDARD_DEVIATION 12.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 24 participants | — |
| Region of Enrollment Austria | 2 participants | — |
| Region of Enrollment Canada | 30 participants | — |
| Region of Enrollment France | 49 participants | — |
| Region of Enrollment Spain | 9 participants | — |
| Region of Enrollment Switzerland | 3 participants | — |
| Sex: Female, Male Female | 87 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 117 |
| other Total, other adverse events | 21 / 117 |
| serious Total, serious adverse events | 40 / 117 |
Outcome results
Primary
Number of Intra- and Peri-procedural Events.
The primary safety endpoint will be a composite of intra- and periprocedural events, including target aneurysmal rupture, vessel perforation or dissection, and thromboembolic event with neurological decline within 24-hours post- procedure or hospital discharge, whichever occurs first.
Time frame: Measured from the start of the procedure through 24 hours or discharge, whichever occurs first.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Robotic Endovascular Procedure | Number of Intra- and Peri-procedural Events. | 4 Events |
Primary
Number of Participants With Procedural Technical Success.
The primary effectiveness endpoint will be defined as successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual for guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy.
Time frame: Measured from the start of the procedure to the end of the procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Endovascular Procedure | Number of Participants With Procedural Technical Success. | 110 Participants |
Secondary
Adverse Events
All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized;
Time frame: Measured from the start of the procedure through end of the study. Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will undergo clinical follow-up th
Secondary
Contrast Fluid Volume
Total contrast used during the procedure
Time frame: Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Endovascular Procedure | Contrast Fluid Volume | 185.4 cc | Standard Deviation 82.3 |
Secondary
Devices Used Robotically
Recorded as successful or unsuccessful in conjunction with the CorPath GRX System
Time frame: Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day
Secondary
Fluoroscopy Time
Total fluoroscopy utilized during the procedure as recorded by the Imaging System
Time frame: Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Endovascular Procedure | Fluoroscopy Time | 51.9 minutes | Standard Deviation 27.4 |
Secondary
Number of Participants With Aneurysm Occlusion
Angiographic assessment of aneurysm occlusion grade according to the Raymond-Roy Occlusion Classification Scale, parent-vessel compromise, and occlusion durability as assessed from an independent core laboratory. Raymond Roy Occlusion Classification Scale - Minimum:1, Maximum: 3b, Higher score meaning worse outcome.
Time frame: Assessed at 180 Day Follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Robotic Endovascular Procedure | Number of Participants With Aneurysm Occlusion | Raymond Roy Classification Scale 1 | 96 Participants |
| Robotic Endovascular Procedure | Number of Participants With Aneurysm Occlusion | Raymond Roy Classification Scale 2 | 2 Participants |
| Robotic Endovascular Procedure | Number of Participants With Aneurysm Occlusion | Raymond Roy Classification Scale 3A | 2 Participants |
| Robotic Endovascular Procedure | Number of Participants With Aneurysm Occlusion | Raymond Roy Classification Scale 3B | 2 Participants |
Secondary
Number of Participants With Aneurysm Occlusion
Angiographic assessment of aneurysm occlusion grade according to the Raymond-Roy Occlusion Classification Scale, parent-vessel compromise, and occlusion durability as assessed from an independent core laboratory. Raymond Roy Occlusion Classification Scale - Minimum:1, Maximum: 3b, Higher score meaning worse outcome.
Time frame: Assessed During Procedure (Post Intervention)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Robotic Endovascular Procedure | Number of Participants With Aneurysm Occlusion | Raymond Roy Classification Scale 1 | 71 Participants |
| Robotic Endovascular Procedure | Number of Participants With Aneurysm Occlusion | Raymond Roy Classification Scale 2 | 5 Participants |
| Robotic Endovascular Procedure | Number of Participants With Aneurysm Occlusion | Raymond Roy Classification Scale 3A | 28 Participants |
| Robotic Endovascular Procedure | Number of Participants With Aneurysm Occlusion | Raymond Roy Classification Scale 3B | 6 Participants |
Secondary
Number of Thromboembolic Events
Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure
Time frame: Measured from the start of the procedure through end of the study (180-days following the robotic-assisted procedure).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Robotic Endovascular Procedure | Number of Thromboembolic Events | 17 Events |
Secondary
Overall Procedure Time
Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter
Time frame: Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Endovascular Procedure | Overall Procedure Time | 117.3 minutes | Standard Deviation 47.3 |
Secondary
Patient Radiation Exposure
DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure
Time frame: Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Endovascular Procedure | Patient Radiation Exposure | 6886135.5 mGy*cm2 | Standard Deviation 25767850.8 |
Secondary
Robotically Deploy Therapeutic Device Into the Target Aneurysm
Defined as successful deployment of therapeutic device into the target aneurysm robotically
Time frame: Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.
Secondary
Robotically Navigate Device to the Target Aneurysm
Defined as successful advancement of device to the target aneurysm robotically.
Time frame: Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.