TARGET Intracranial Aneurysm Coiling Registry
This study is currently recruiting participants.
Verified April 2013 by Medical College of Wisconsin
Sponsor:
Osama Zaidat, MD, MSc
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
Osama Zaidat, MD, MSc, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01748903
First received: December 7, 2012
Last updated: April 5, 2013
Last verified: April 2013
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Purpose
The purpose of this prospective registry is to collect real world, post-marketing data on the use of Stryker Target® 360° and Target® 2D coils for the embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 150 patients presenting with intracranial aneurysms suitable for coil embolization will be enrolled at approximately 10 sites. A post hoc analysis comparing Target® 360° and Target® 2D coil technical and clinical endpoints will be performed.
| Condition | Intervention | Phase |
|---|---|---|
|
Intracranial Aneurysms |
Device: Embolization using Target 360° and Target 2D Coils |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | TARGET Intracranial Aneurysm Coiling Registry: A Prospective Clinical Efficacy and Safety Study of Stryker Target® 360° and Target® 2D Coils |
Resource links provided by NLM:
Further study details as provided by Medical College of Wisconsin:
Primary Outcome Measures:
- Packing Density [ Time Frame: At immediate post-procedure (Day 1) ] [ Designated as safety issue: No ]Packing density will be calculated based on aneurysm volume and amount of coil used during the embolization procedure.
Secondary Outcome Measures:
- Occlusion Rate [ Time Frame: At immediate post-procedure (Day 1) and 3-9 month follow-up ] [ Designated as safety issue: No ]Angiographic occlusion of the aneurysm will be adjudicated by an independent core lab using immediate post-procedure and 3-9 month follow-up angiography.
- Aneurysm Re-access Rate [ Time Frame: At end of study procedure (Day 1) ] [ Designated as safety issue: No ]The rate of re-assess (Microcatheter kick-back rate) of the target aneurysm will be captured during the procedure.
- Time of Fluoroscopic Exposure [ Time Frame: At immediate post-procedure (Day 1) ] [ Designated as safety issue: Yes ]Total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coil embolization procedure.
- Overall Procedure Time [ Time Frame: At Immediate post-procedure (Day 1) ] [ Designated as safety issue: No ]The overall procedure time will be captured from the time of guide catheter placement to the end of the coil embolization procedure.
- Aneurysm Recurrence [ Time Frame: 3-9 month follow-up ] [ Designated as safety issue: No ]
- Aneurysm Re-treatment Rate [ Time Frame: 3-9 month follow-up ] [ Designated as safety issue: No ]Aneurysm re-treatment rates will be tracked and recorded during the 3-9 month follow-up
- Aneurysm Bleed and Re-bleed Rate [ Time Frame: 3-9 month follow-up ] [ Designated as safety issue: Yes ]Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.
- Treatment-related Morbidity and Mortality [ Time Frame: from study procedure (Day 1) to 3-9 month follow-up ] [ Designated as safety issue: Yes ]Treatment-related morbidity and morality will be tracked and recorded from study procedure through the 3-9 month follow-up.
- Modified Rankin Score [ Time Frame: At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up ] [ Designated as safety issue: No ]Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.
- Device-related serious adverse events [ Time Frame: From the study procedure (Day 1) until 3-9 month follow up ] [ Designated as safety issue: Yes ]Procedural and post-procedural serious adverse events related to the device and/or procedure will be captured and recorded at the end of the procedure and until the patient has completed the 3-9 month follow-up.
- Length of hospital stay [ Time Frame: At hospital discharge (Day 3) ] [ Designated as safety issue: No ]Length of hospital stay will be recorded at the time of patient discharge.
- Technical and clinical endpoints of Target 360° and 2D coils [ Time Frame: 3-9 month follow-up ] [ Designated as safety issue: No ]A post hoc analysis comparing Target 360° and 2D coil primary and secondary technical and clinical endpoints will be performed upon final data analysis.
| Estimated Enrollment: | 150 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Embolization using Target 360° and Target 2D Coils
Subjects will receive Target 360° and/or Target 2D Coils for the treatment of their intracranial aneurysm. All attempts should be made by the operator to coil the target aneurysm as follows:
|
Device: Embolization using Target 360° and Target 2D Coils
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is 18 years or older.
- Patient has a documented, saccular intracranial aneurysm, unruptured or ruptured, suitable for embolization with coils.
- Patient has a Hunt and Hess Score of 3 or less.
- Patient or patient's legally authorized representative has provided written informed consent.
- Patient is willing to and can comply with study follow-up requirements.
Exclusion Criteria:
- Patient is < 18 years old.
- Dissecting aneurysm.
- Patients in whom the target aneurysm will be treated with coils other than Stryker Target® 360° and Target® 2D coils.
- Target aneurysm is fusiform.
- Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748903
Contacts
| Contact: Alicia C Castonguay, PhD | 4148055439 | acastonguay@mcw.edu |
Locations
| United States, Wisconsin | |
| Medical College of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Alicia C Castonguay, PhD 414-805-5439 acastonguay@mcw.edu | |
| Principal Investigator: Osama O Zaidat, MD, MS | |
Sponsors and Collaborators
Osama Zaidat, MD, MSc
Stryker Neurovascular
Investigators
| Principal Investigator: | Osama O Zaidat, MD, MS | Medical College of Wisconsin |
More Information
No publications provided
| Responsible Party: | Osama Zaidat, MD, MSc, Professor of Neurology, Neurosurgery, & Radiology, Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT01748903 History of Changes |
| Other Study ID Numbers: | 19180 |
| Study First Received: | December 7, 2012 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Medical College of Wisconsin:
|
intracranial aneurysm cerebral aneurysm packing density Target Coils aneurysm embolization |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013