Intracranial Aneurysms
Conditions
Keywords
Intracranial saccular aneurysms, Endovascular coiling therapy, Retreatment, Raymond scale, Matrix, GDC, Guglielmi Detachable Coil
Brief summary
Primary Objectives: * To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. TAR is defined as clinically relevant recurrence resulting in: target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause. * To correlate defined angiographic endpoints with TAR rates and assess their predictive value, thereby providing a framework to establish clinically relevant endpoints for future studies. Secondary Objectives: * To evaluate device characteristics, incidence and severity of device-related adverse events, including death, neurological deterioration and changes in functional abilities. * To establish angiographic recurrence rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. * To explore an experimental, quantitative and volumetric endpoint and correlate these with existing qualitative assessments.
Detailed description
The endovascular treatment of intracranial aneurysms has become an accepted alternative to surgical repair given the many recent advances with neurointerventional devices and procedures. The introduction of GDC coils in 1993 provided physicians and their patients a less invasive treatment option. Additionally, the results of two large international trials, ISAT and ISUIA, have shown the benefits of endovascular treatment over surgery for treatment of specific types of aneurysms. One limitation of endovascular coil embolization is aneurysm recurrence or recanalization which is not infrequently observed angiographically at follow up. Aneurysm recanalization may be a result of aneurysm morphology, anatomic location and flow orientation, aneurysm regrowth or the degree of coil compaction. Despite the widespread adoption of endovascular aneurysm coiling, there remains much to be learned about the efficacy and optimization of this treatment modality. The goal of endovascular embolization of intracranial aneurysms is to prevent rupture or re-rupture. Fortunately, the incidence of aneurysm rupture following coil embolization is very low. Follow-up angiographic analysis to evaluate the occlusion and stability of the treated aneurysm provides a surrogate endpoint against which to weigh the likelihood of rupture/re-rupture. However, angiographic interpretation is subjective, operator dependent and can be influenced by multiple confounding variables. The MAPS trial will examine Target Aneurysm Recurrence Rates: clinically relevant recurrence rates resulting in target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. The trial will compare TAR rates to recurrences measured by angiographic analysis and assess the utility of angiographic analysis for predicting clinically relevant recurrences.
Interventions
DEVICEMatrix 2® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil
DEVICEGDC® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil
Sponsors
Stryker Neurovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is between 18 and 80 years of age (inclusive). 2. Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils. 3. Both GDC® Coils and Matrix 2® Coils (Every attempt should be made to treat with as much randomized coil type as possible to achieve optimal occlusion.) are treatment options (all shapes allowed with exception of GDC VortX Coil). 4. Target aneurysm can be adequately coiled at index procedure (NO staged coiling procedures). If a Neuroform stent is to be placed during a separate preliminary procedure, then screening and enrollment for the coiling procedure must take place after the stenting procedure is completed. 5. Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician. 6. Patient (or patient's legally authorized representative for centers in the United States) has provided written informed consent. 7. Patient is willing and able to comply with protocol follow-up requirements.
Exclusion criteria
1. Patient is \< 18 or \> 80 years old. 2. Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting). 3. Target aneurysm is \> 20 mm maximum luminal dimension, \< 4 mm maximum luminal dimension. 4. Target aneurysm has been previously treated by surgery or endovascular therapy. 5. Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques. 6. Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm. 7. Patient presents with Modified Rankin Score 4 or 5 at baseline. 8. Patient is concurrently enrolled in another investigational drug or device study unless permission is granted by the sponsor. 9. Patient has known hypersensitivity to Polyglycolic Polylactic Acid (PGLA), platinum, nickel, stainless steel or structurally related compounds found in Matrix 2® Coils and/or GDC® Coils. 10. Patients who have had or could have a severe reaction to contrast agents that cannot be adequately pre-medicated prior to the coiling procedure. 11. Patients who are unable to complete scheduled follow up assessments at the enrolling center due to limited life expectancy (\< 12 months), comorbidities or geographical considerations. 12. Planned use of adjunctive therapy stents except Neuroform is not allowed. 13. Patients with Moya-Moya disease, AVMs, AV fistula, intracranial tumors, intracranial hematoma (unrelated to target aneurysm), significant atherosclerotic stenosis, tortuousity or other conditions preventing access to the target aneurysm. 14. Patients with multiple aneurysms. 15. Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion of the investigator. 16. Female patient has a positive pregnancy assessment at baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause. | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic Assessments | Reintervention or 12 months | Number of participants with angiographic assessment of complete obliteration. |
| Neurological Assessments | 12 months | The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects same or better. |
| Technical Procedure Success | Post-procedure | — |
| Target Aneurysm Recurrence | 2 years | — |
Countries
Australia, Canada, China, France, Germany, Mexico, Norway, Spain, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Enrollment in the study occurred over 31 months at 26 sites in the US and 17 International. Each site was allowed to enroll up to 60 consecutive subjects; recruitment for the study was competitive. The first subject was enrolled on 29 March 2007 and the enrollment completed on 21 October 2009. A total of 626 subjects were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Matrix 2® Coils for Endovascular Aneurysm Occlusion Matrix 2® Coils for endovascular aneurysm occlusion
Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil | 311 |
| GDC® Coils for Endovascular Aneurysm Occlusion GDC® Coils for endovascular aneurysm occlusion
GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil | 315 |
| Total | 626 |
Baseline characteristics
| Characteristic | Matrix 2® Coils for Endovascular Aneurysm Occlusion | GDC® Coils for Endovascular Aneurysm Occlusion | Total |
|---|---|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 11.6 | 54.4 years STANDARD_DEVIATION 13.2 | 55.0 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment Australia | 1 participants | 3 participants | 4 participants |
| Region of Enrollment Canada | 16 participants | 15 participants | 31 participants |
| Region of Enrollment China | 7 participants | 9 participants | 16 participants |
| Region of Enrollment France | 17 participants | 15 participants | 32 participants |
| Region of Enrollment Germany | 13 participants | 10 participants | 23 participants |
| Region of Enrollment Mexico | 1 participants | 2 participants | 3 participants |
| Region of Enrollment Norway | 6 participants | 5 participants | 11 participants |
| Region of Enrollment Spain | 46 participants | 44 participants | 90 participants |
| Region of Enrollment Turkey | 4 participants | 6 participants | 10 participants |
| Region of Enrollment United Kingdom | 17 participants | 16 participants | 33 participants |
| Region of Enrollment United States | 183 participants | 190 participants | 373 participants |
| Sex: Female, Male Female | 229 Participants | 211 Participants | 440 Participants |
| Sex: Female, Male Male | 82 Participants | 104 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 112 / 311 | 120 / 315 |
| serious Total, serious adverse events | 85 / 311 | 80 / 315 |
Outcome results
Primary
Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.
Time frame: 12 months
Population: A totoal of 630 subjects were planned for the study. All enrolled MAPS trial subjects' data is included in the ITT anaylsis except for four subjects who were excluded due to the following reasons: one subject did not have an aneurysm and three subjects', a the request of the IRB, due to non GCP compliance in obtaining the inofrmed consent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matrix Coils | Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause. | 34 participants |
| GDC Coils | Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause. | 35 participants |
Comparison: Intent-to-Treat, All Subjects (N=626) GDC (N=315) Matrix (N=311) All Subjects (N=626) Subjects Who Met Primary Endpoint 35 (11.1%) 34 (10.9%) 69 (11.0%)p-value: 0.76Log Rank
Secondary
Angiographic Assessments
Number of participants with angiographic assessment of complete obliteration.
Time frame: Reintervention or 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matrix Coils | Angiographic Assessments | 87 participants |
| GDC Coils | Angiographic Assessments | 89 participants |
Secondary
Neurological Assessments
The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects same or better.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matrix Coils | Neurological Assessments | 90.1 percentage of participants |
| GDC Coils | Neurological Assessments | 88.3 percentage of participants |
Secondary
Target Aneurysm Recurrence
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matrix Coils | Target Aneurysm Recurrence | 44 participants |
| GDC Coils | Target Aneurysm Recurrence | 46 participants |
Secondary
Target Aneurysm Recurrence
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matrix Coils | Target Aneurysm Recurrence | 42 participants |
| GDC Coils | Target Aneurysm Recurrence | 42 participants |
Secondary
Target Aneurysm Recurrence
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matrix Coils | Target Aneurysm Recurrence | 43 participants |
| GDC Coils | Target Aneurysm Recurrence | 45 participants |
Secondary
Technical Procedure Success
Time frame: Post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matrix Coils | Technical Procedure Success | 96.8 percentage of participants |
| GDC Coils | Technical Procedure Success | 97.5 percentage of participants |