A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms
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|ClinicalTrials.gov Identifier: NCT03642639|
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : January 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Aneurysms||Device: Spectra Micrusframe and Spectra Galaxy coils||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||850 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi-center, Single Arm Study to Obtain "Real World" Clinical Data and Characterize the Acute and Long-term Performance of the MICRUSFRAME and GALAXY Coils for the Endovascular Treatment of Intracranial Aneurysms|
|Actual Study Start Date :||August 23, 2018|
|Estimated Primary Completion Date :||January 29, 2021|
|Estimated Study Completion Date :||January 28, 2022|
Spectra Micrusframe and Spectra Galaxy coils
Device: Spectra Micrusframe and Spectra Galaxy coils
Spectra MICRUSFRAME and Spectra GALAXY Coils
- Occlusion Rate [ Time Frame: 12 Months ]Occlusion rate at 12 Months post procedure
- 1. Packing Density [ Time Frame: From enrollment to end of treatment at 12 months ]Packing density will be evaluated based on aneurysm volume and the coils used during the procedure.
- 2. Complete occlusion rate [ Time Frame: 12 month ]Complete occlusion rate at 12 month follow-up
- 3. Recanalization Rate [ Time Frame: 12 Months ]Recanalization Rate: Any worsening of occlusion grading at 12 Month follow-up
- 4. Device related serious adverse events [ Time Frame: 12 Months ]Any device related serious adverse events will be reported through 12 month follow-up
- 5. Retreatment Rate [ Time Frame: 12 Months ]Aneurysm re-treatment rates will be tracked and recorded during the 12 month follow-up
- 6. Modified Rankin Score [ Time Frame: 12 Months ]
Modified Rankin Score (Scale from 0-6) at 12 Months. 0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
- 7. Length of hospital stay [ Time Frame: From enrollment to 12 Months ]Hospital stay length will be recorded
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642639
|Contact: Lillian Maemail@example.com|
|United States, New York|
|Mount Sinai Hospital||Recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: Reade De Leacy, MD|
|United States, Ohio|
|Mercy Health St. Vincent Medical Center||Recruiting|
|Toledo, Ohio, United States, 43604|
|Principal Investigator: Osama Zaidat, MD, MS|
|Principal Investigator:||Reade De Leacy||Mount Sinai Hospital, New York|
|Principal Investigator:||Osama Zaidat||Mercy Health St. Vincent Hospital|