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Coils
Coiling for Brain Aneurysm (STERLING Trial)
N/A
Recruiting
Led By Reade De Leacy
Research Sponsored by Cerenovus, Part of DePuy Synthes Products, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is between 21 and 80 years of age
Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
STERLING Trial Summary
This trial will look at the safety and effectiveness of a new type of coil used to treat aneurysms.
Who is the study for?
This trial is for adults aged 21-80 with a brain aneurysm (a bulge in a blood vessel in the brain) that can be treated with coils. Participants must be able to follow the study's procedures and visits.Check my eligibility
What is being tested?
The performance of two types of coils, MICRUSFRAME and GALAXY, is being evaluated for treating both ruptured and unruptured intracranial saccular aneurysms.See study design
What are the potential side effects?
Potential side effects may include complications related to the procedure such as bleeding or further damage to blood vessels, reaction to materials used, or issues arising from coil placement.
STERLING Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 80 years old.
Select...
I have a brain aneurysm that can be treated with coiling.
STERLING Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occlusion Rate
Secondary outcome measures
1. Packing Density
2. Complete occlusion rate
3. Recanalization Rate
+4 moreSTERLING Trial Design
1Treatment groups
Experimental Treatment
Group I: CoilsExperimental Treatment1 Intervention
MICRUSFRAME and GALAXY coils
Find a Location
Who is running the clinical trial?
Cerenovus, Part of DePuy Synthes Products, Inc.Lead Sponsor
8 Previous Clinical Trials
4,721 Total Patients Enrolled
2 Trials studying Aneurysm
71 Patients Enrolled for Aneurysm
Reade De LeacyPrincipal InvestigatorMount Sinai Hospital, New York
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Aneurysm
50 Patients Enrolled for Aneurysm
Osama ZaidatPrincipal InvestigatorMercy Health St. Vincent Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a procedure on an unruptured aneurysm.I am between 21 and 80 years old.I have a brain aneurysm that can be treated with coiling.I have a spindle-shaped bulge in my blood vessel.I need treatment for more than one aneurysm.I am able and willing to follow the study's requirements.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Coils
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