Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study
Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study
Treatment of vascular malformations requires the placement of a needle within anatomically
 non well defined, pathological vessels, which may be as small as 1 mm, with the current state
 of the art relying exclusively on two dimensional fluoroscopy images for guidance. The
 investigators hypothesize that the combination of stereotactic image guidance with existing
 targeting methods will result in faster and more reproducible needle placements.
This prospective study aims to investigate the feasibility of the utilization of stereotactic
 image guidance technology for the needle based percutaneous treatment of peripheral vascular
 malformations. The specific device to be utilized is the CAS-One IR system, CE marked for use
 with needle based procedures in combination with medical image data including MRI data, as
 required by this study.

 Utilizing feedback from the stereotactic image guidance system, the interventionalist will
 attempt to place the needle within the malformation. The position and orientation of the
 needle relative to the anatomy will be displayed on 2D slices from the MRI, as well as
 relative to a 3D volume rendering of the patient anatomy constructed from MRI data. The
 position of the needle relative to the desired position within the malformation will be
 evaluated utilizing fluoroscopy.

 If necessary the position of the needle will be adjusted, this adjustment can be performed
 utilizing navigated feedback or standard fluoroscopy feedback at the discretion of the
 physician. The final position of the needle will be confirmed on intra-operative DSA imaging
 and the sclerosant will be applied according to standard clinical protocols.

 This single-centre pilot study will involve a total of 10 patients suffering from peripheral
 vascular malformations. Only non-emergency adult patients will be considered for inclusion in
 this trial. Inclusion will be at the discretion of the treating physician and patient. As the
 study is designed as a pilot trial, no comparator is considered and no blinding performed.
 The trial will be performed over a period of nine months.
Inclusion Criteria:

 -  Patients with venous or mixed venous-lymphatic malformation

 -  Patients which are regular scheduled for a percutaneous treatment of a vascular
 malformation

 -  Informed Consent as documented by signature

 Exclusion Criteria:

 -  Age < 18 years