A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|