Prospective Packing Density With Target Coils I

Status unconfirmed · Not applicable

Conditions studied: Intracranial Aneurysm

In brief

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 to 25 eligible subjects with ruptured or unruptured intracranial saccular aneurysms between 4-20mm (maximum dimension), who consent to study participation, will be treated with Stryker Target Detachable Coils. Historical data from patients enrolled in the MAPS trial at the single center will be the control arm of the trial and reviewed for comparison to the prospective arm. In the control arm, the subjects received Stryker Matrix2 Detachable Coils and Guglielmi Detachable Coils and packing density was not measured prior to these procedures. The Pro-Pack Trial will evaluate the outcomes of the subjects treated with Target Coils, in whom the packing density will be actively calculated prior to coil selection. This will serve to establish that a higher packing density can be obtained by the change in methodology of coil selection and a higher packing density with lower recurrence rates.

Key facts

Study ID

NCT02292017

Run by

Tennessee Neurovascular Institute, LLC

People needed

25

Starts

2014-10-01

Expected to finish

2019-08-01

Last updated by the study team

2018-09-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion on the investigator.
• Female patient has a positive pregnancy assessment at baseline.

Where it is running

• Fort Sanders Regional Medical Center — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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