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|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS100001 / PSS001 |
| Date Original Plan Accepted |
05/31/2012
|
| Date Current Plan Accepted |
05/31/2012
|
| Study Name |
HydroCoil Study
|
| Device Name |
Microvention hydrocoil-soft-frame
|
| Root Document Number |
K020434
K032590
K033836
K041551
K050954
K070656
K080666
K090357
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
External Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Retrospective and prospective, multi-center, single arm study with two study groups
|
| Study Population |
Adult 21+
|
| Sample Size |
Group 1: A total of 324 patients from 4 studies/registries who were provided the HydroCoil device with a minimum of 18 months follow-up were analyzed for incidences of hydrocephalus and aseptic meningitis. Information from these patients was used as the primary analysis to address the 522 order. Group 2: A total of 488 patients from 6 published articles/registries who were provided the HydroCoil device with< 18 months or no follow-up were analyzed for incidences of hydrocephalus and aseptic meningitis. The related information was primarily obtained from the published literature and was summarized as supportive information only.
|
| Key Study Endpoints |
Incidence of hydrocephalus; Incidence of aseptic meningitis; Aneurysm location; Aneurysm size; Number of HydroCoils and total number of coils deployed; HydroCoil length and total coil length. Based on the aneurysm size and coils used, the HydroCoil and total packing density will be calculated
|
| Follow-up Visits and Length of Follow-up |
Data were collected for patients with a minimum of 18 months follow-up. This information was used for the primary analysis. Additional information was collected for patients with a minimum of < 18 months or no available follow-up. This group was not included in the primary analysis, but was summarized as supportive information only.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Group 1: 313 patients. Group 2: 488 patients
|
| Actual Number of Sites Enrolled |
Group 1: not reported. Group 2: not reported
|
| Patient Followup Rate |
Group 1: 97%
Group 2: not reported
|
| Final Safety Findings |
1) The unexplained hydrocephalus incidence 0.019 with a 95% CI of (0.0084, 0.039). The rate is not statistically different from the rate seen in subjects treated with bare platinum coils, given comparable patient populations. 2)The unexplained aseptic meningitis incidence is 0.0032 with a 95% CI of (0.00016, 0.017). The rate is not statistically different from the rate seen in subjects treated with bare platinum coils, given comparable patient populations. 3)There is no significant difference in terms of the HydroCoil packing density between patients with no hydropcephatus (66%) and patients with hydropcephatus (62%). However, there is significant difference regarding the number HydroCoil used and the HydroCoil length. The mean number of HydroCoil used in patients reported hydrocephalus (9.2) is twice as many as those used in patients without hydrocephalus (4.2). The average HydroCoil length in patients reported hydrocephalus (127 cm) is three times of that in patients without hydrocephalus (41 cm). 4) No statistical difference in hydrocephalus between the HydroCoil group and the control group was detected at the aneurysm location (Fisher Exact P-value=0.379 at Basilar tip; Fisher Exact P-value=0.463 at non-Basilar tip) or sizes (Fisher Exact P-value=0.354 for aneurysm>10mm; Fisher Exact P-value=0.498 for aneurysm between 5mm and10mm)
|
| Final Effectiveness Findings |
1) The unexplained hydrocephalus incidence 0.019 with a 95% CI of (0.0084, 0.039). The rate is not statistically different from the rate seen in subjects treated with bare platinum coils, given comparable patient populations.
2.) The unexplained aseptic meningitis incidence is 0.0032 with a 95% CI of (0.00016, 0.017). The rate is not statistically different from the rate seen in subjects treated with bare platinum coils, given comparable patient populations.
3) There is no significant difference in terms of the HydroCoil packing density between patients with no hydropcephatus (66%) and patients with hydropcephatus (62%). However, there is significant difference regarding the number HydroCoil used and the HydroCoil length. The mean number of HydroCoil used in patients reported hydrocephalus (9.2) is twice as many as those used in patients without hydrocephalus (4.2). The average HydroCoil length in patients reported hydrocephalus (127 cm) is three times of that in patients without hydrocephalus (41 cm).
4) No statistical difference in hydrocephalus between the HydroCoil group and the control group was detected at the aneurysm location (Fisher Exact P-value=0.379 at Basilar tip; Fisher Exact P-value=0.463 at non-Basilar tip) or sizes (Fisher Exact P-value=0.354 for aneurysm>10mm; Fisher Exact P-value=0.498 for aneurysm between 5mm and10mm)
|
| Study Strengths and Weaknesses |
Strength: Retrospective and prospective analysis.
Weakness: the study is a single arm study against historical control. Patients in the treatment arm are derived from two separate clinical studies and prospectively followed. The rates of hydrocephalus (or aseptic meningitis) in patients treated with Bare Platinum Coil of the control arm were estimated from previous medical experience. Therefore, confounding factors cannot be well controlled in the single arm study and confounding bias could not be ruled out. Conclusion to be drawn from the study must be interpreted with caution.
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| Recommendations for Labeling Changes |
No
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