Intracranial Aneurysm
Conditions
Brief summary
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial aneurysms.
Detailed description
The data will be collected in consecutive subjects treated with the commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CORDIS ENTERPRISE™ VRD during the index procedure. While only limited inclusion or exclusion criteria are specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up up to 6 months. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the VRD placement, coiling procedure, application of antiplatelet medication and any other medical therapy to be provided according to local usual practice.
Interventions
DEVICEVascular Reconstruction Device
CORDIS ENTERPRISE™ VRD
Sponsors
Codman & Shurtleff
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The subject must be \>= 18 years of age and less than 80 years. * Diagnosis of a ruptured (Hunt and Hess Grade I - III) or unruptured intracranial aneurysm at the time of the treatment * Subject (or his/her legal representative) provides written informed consent for the use of his/her peri-procedural and follow-up data
Exclusion criteria
* Diagnosis of Hunt and Hess Grade IV or V subarachnoid hemorrhage at the time of the treatment * Severe co-morbidity associated with a life-expectancy of less than six months * Poor neurological status at baseline * Known allergies to Nitinol metal * Known allergies to aspirin, heparin, ticlopidine, or clopidogrel or unable or unwilling to tolerate therapy * Participation in an investigational drug or another device study is only allowed after written approval of the coordinating investigator or Cordis Medical Monitor. * Implantation of an intracranial stent associated with the symptomatic distribution within 12 weeks prior to the index procedure * Implantation of carotid stent associated with the symptomatic distribution within 12 weeks prior to the index procedure * Atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE) | Intra-procedure | Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency. Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device or Procedure Related Adverse Events (AEs) | index procedure to discharge; an average of 3.8 days | Incidence of device or procedure related adverse events during the index procedure and till discharge |
| Satisfactory Coil Mass Position | 6 months | Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically |
| Aneurysm Occlusion | post procedure to 6 months | Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm) |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 Endovascular All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device and were consented before the procedure. Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | 1 Endovascular |
|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 12.6 |
| Medical History Cancer | 6 Participants |
| Medical History Cardiovascular Disease | 4 Participants |
| Medical History Chronic Pulmonary Disease | 1 Participants |
| Medical History Diabetes | 2 Participants |
| Medical History Dyslipidemia/Hypercolesterolemia | 4 Participants |
| Medical History Endocrice/Metabolic Disease | 1 Participants |
| Medical History Hypertension | 38 Participants |
| Medical History Immunologic | 1 Participants |
| Medical History Obesity | 1 Participants |
| Medical History Other | 4 Participants |
| Medical History Renal Disease | 2 Participants |
| Medical History Smoking | 1 Participants |
| Medical History Vasculitis | 1 Participants |
| Neurological History Cranial Nerve Palsy/ Paresis | 2 Participants |
| Neurological History Epilepsy | 3 Participants |
| Neurological History Recurrent Headache | 18 Participants |
| Neurological History TIA/CVA | 21 Participants |
| Previous Neurological Surgical Procedures | 36 Participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 105 |
| serious Total, serious adverse events | 5 / 105 |
Outcome results
Primary
The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)
Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency. Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
Time frame: Intra-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Endovascular | The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE) | 64 participants |
Secondary
Aneurysm Occlusion
Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)
Time frame: post procedure to 6 months
Population: no data was available for 21 subjects post-procedure and 26 subjects at 6 months follow-up; either because the investigator didn't submit the images or due to poor quality of the submitted images
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 Endovascular | Aneurysm Occlusion | Complete Occlusion (Raymond 1) | 17 participants |
| 1 Endovascular | Aneurysm Occlusion | Neck Remnant (Raymond 2) | 19 participants |
| 1 Endovascular | Aneurysm Occlusion | Residual Aneurysm (Raymond 3) | 48 participants |
| Endovascular - Occlusion Results at 6 Months Follow-up | Aneurysm Occlusion | Complete Occlusion (Raymond 1) | 46 participants |
| Endovascular - Occlusion Results at 6 Months Follow-up | Aneurysm Occlusion | Neck Remnant (Raymond 2) | 8 participants |
| Endovascular - Occlusion Results at 6 Months Follow-up | Aneurysm Occlusion | Residual Aneurysm (Raymond 3) | 25 participants |
Secondary
Device or Procedure Related Adverse Events (AEs)
Incidence of device or procedure related adverse events during the index procedure and till discharge
Time frame: index procedure to discharge; an average of 3.8 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Endovascular | Device or Procedure Related Adverse Events (AEs) | 14 participants |
Secondary
Satisfactory Coil Mass Position
Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
Time frame: 6 months
Population: no data was available for 33 subjects; either because the investigator didn't submit the images or due to poor quality of the submitted images
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Endovascular | Satisfactory Coil Mass Position | 60 participants |