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Prospective Packing Density With Target Coils I

NCT02292017 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-09-11

No results posted yet for this study

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 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.

Conditions

  • Intracranial Aneurysm

Interventions

DEVICE

Embolization of intracranial aneurysm

Cerebral angiogram will be performed, target aneurysm measurements are performed including dome height, width, and depth as well as the neck length. Aneurysm volume will be calculated. During the embolization, framing, filling, and finishing should be done with Target Coils. In the event of aneurysms with a wide neck a Neuroform Stent may be used to ensure the best clinical and angiographic outcome. Immediate post procedure angiography is performed using the same pre-treatment views to assess results and complications.

Sponsors & Collaborators

  • Tennessee Neurovascular Institute, LLC

    lead OTHER

Principal Investigators

  • Keith Woodward, MD · Tennessee Neurovascular Institute, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-02-01
Completion
2019-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02292017 on ClinicalTrials.gov