Status:
UNKNOWN
Prospective Packing Density With Target Coils I
Lead Sponsor:
Tennessee Neurovascular Institute, LLC
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a prospective single center trial investigating the effects of prospectively measuring packing density prior to choosing Target Coils for the treatment of intracranial saccular aneurysms. Up t...
Detailed Description
The Pro Pack Trial will evaluate the outcomes of subjects treated with Target Coils, in whom the packing density is actively calculated prior to coil selection. Selecting the coil with the best volume...
Eligibility Criteria
Inclusion
- Patient is between 18 and 85 years of age (inclusive).
- Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils.
- Target® Coils are considered a treatment option. Every attempt should be made to treat with Target coils as possible to achieve optimal occlusion.
- Target aneurysm can be adequately coiled at index procedure (NO staged coiling procedures).
- Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician.
- Patient or patient's legally authorized representative has provided written informed consent.
- Patient is willing and able to comply with protocol follow-up requirements.
Exclusion
- Candidates must be excluded from the study if ANY of the following criteria are met at the time of screening:
- Patient is \<18 or \>80 years old.
- Target aneurysm is not saccular in nature (mycotic, fusiform, and dissecting).
- Target aneurysm is \>20 mm maximum luminal dimension, \<4 mm maximum luminal dimension.
- Target aneurysm has been previously treated by surgery or endovascular therapy.
- Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques.
- Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm.
- Patient presents with Modified Rankin Score 4 or 5 at baseline.
- Patient is concurrently enrolled in another investigational drug or device study unless the sponsor grants permission.
- Patient has known hypersensitivity to platinum, nickel, stainless steel or structurally related compounds found in Target® Coils.
- Patients who have had or could have a severe reaction to contrast agents that cannot be adequately pre-medicated prior to the coiling procedure.
- Patients who are unable to complete scheduled follow up assessments at the enrolling center due to limited life expectancy (\<12 months), comorbidities or geographical considerations.
- Planned use of adjunctive therapy stents except Neuroform is not allowed.
- Patients with Moya-Moya disease, AVMs, arteriovenous fistula, intracranial tumors, intracranial hematoma (unrelated to target aneurysm), significant atherosclerotic stenosis, tortuosity or other conditions preventing access to the target aneurysm.
- 15\. Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion on the investigator.
- 16\. Female patient has a positive pregnancy assessment at baseline.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02292017
Start Date
October 1 2014
End Date
August 1 2019
Last Update
September 11 2018
Active Locations (1)
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1
Fort Sanders Regional Medical Center
Knoxville, Tennessee, United States, 37916