Aneurysms
Conditions
Brief summary
A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
Detailed description
A registry to collect real world data on the use of Cerenovus coils. The study will be a post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
Interventions
DEVICEMICRUSFRAME and GALAXY coils
MICRUSFRAME and GALAXY Coils
Sponsors
Cerenovus, Part of DePuy Synthes Products, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is between 21 and 80 years of age 2. Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils 3. Patient is able and willing to comply with protocol and follow-up requirements
Exclusion criteria
1. Pre-planned staged procedure on unruptured aneurysm 2. More than one aneurysm requiring treatment during the course of study 3. Fusiform aneurysm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Adequate Occlusion (Modified Raymond-Roy I or II Classification) as Assessed by the Independent Core Lab Report of the Target Aneurysm at 1 Year Without Retreatment | At 1 year Post Procedure on Day 1 | Number of participants who achieved adequate occlusion as assessed by the independent core lab report of the target aneurysm at 1 year without retreatment was reported. Adequate occlusion was defined as the achievement of a Modified Raymond-Roy classification of the aneurysm at 1 year without retreatment. Modified Raymond-Roy Classification scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Packing Density Percentage (%) as Assessed by Independent Core Lab | During procedure (Day 1) | Packing density was defined as the ratio of the volume of coils to the volume of the coiled part of the aneurysm achieved during the procedure. Packing density is expressed as percentage. |
| Number of Participants With Complete Occlusion at 1 Year as Assessed by the Independent Core Lab (Modified Raymond-Roy I Classification) | At 1 year Post Procedure on Day 1 | Number of participants with complete occlusion at 1 year was reported as assessed by the independent core lab was reported. Complete occlusion was defined as achieving Modified Raymond-Roy I classification at 1 year, as assessed by the independent core lab. Modified Raymond-Roy I or II Classification scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall. |
| Recanalization Rate at 1 Year as Assessed by Independent Core Lab | At 1 year Post Procedure on Day 1 | Recanalization rate is defined as number of participants with recanalization. Recanalization was defined as a worsening in aneurysm occlusion grading using the Modified Raymond-Roy Classification (MRRC) scale. MRRC scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall. |
| Number of Participants With Modified Rankin Score (mRS) 0-2 With Unruptured Aneurysms | From baseline (Day 1 of procedure) to 1 year post procedure on Day 1 | Number of participants with mRS 0-2 with unruptured aneurysm was reported. The Modified Rankin Scale (mRS) is a 7 point measure of functional outcome ranging from 0 to 6, where higher scores indicate greater disability. A score of 0 reflects no symptoms, 1 denotes no significant disability despite minor symptoms, 2 indicates slight disability with independence in personal affairs, 3 corresponds to moderate disability requiring some help but able to walk unassisted, 4 represents moderately severe disability with dependence for bodily needs and inability to walk alone, 5 signifies severe disability requiring constant care, and 6 indicates death. Increasing scores indicate worsening outcomes. |
| Number of Participants With Retreatment (Surgical or Endovascular) | From baseline (Day 1 of procedure) to 1 year post procedure on Day 1 | Number of participants with any retreatment (surgical or endovascular) was reported. Retreatment is defined as any type of additional treatment (surgical or endovascular) of the target aneurysm after the index procedure. |
| Number of Participants With Device Related Serious Adverse Events (SAEs) | From Day of procedure (Day 1) up to 1 year | An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. A serious adverse event (SAE) is defined as an adverse event that led to death, led to serious deterioration in the health of the participant, users, other persons as defined by one or more of the following: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function including chronic diseases, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function led to fetal distress, fetal death or a congenital abnormality or birth defect including physical or mental impairment. |
Countries
Belgium, France, Germany, Israel, Italy, Japan, Portugal, Spain, Switzerland, United States
Contacts
PRINCIPAL_INVESTIGATORReade De Leacy
Mount Sinai Hospital, New York
PRINCIPAL_INVESTIGATOROsama Zaidat
Mercy Health St. Vincent Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58.2 years STANDARD_DEVIATION 11.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 72 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 405 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 226 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 68 Participants |
| Race (NIH/OMB) Black or African American | 61 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 218 Participants |
| Race (NIH/OMB) White | 354 Participants |
| Sex: Female, Male Female | 489 Participants |
| Sex: Female, Male Male | 214 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 723 |
| other Total, other adverse events | 5 / 703 |
| serious Total, serious adverse events | 20 / 703 |
Outcome results
None listed