Implantation Procedure
B.E.S.T Checklist for Proper Implantation Procedure
Note!
The following information provides a summary of the INTERCEPT study implantation and follow-up procedures. Do not use this webpage for instructions on INTERCEPT study procedures. All study procedures must be performed according to the complete instructions as provided in the latest approved versions of the INTERCEPT Protocol and Vine™ System Instructions for Use. To confirm that you are using the latest approved versions of these documents, contact the INTERCEPT study sponsor or CRO at the information provided on the Contact Us page.
Proper training must be completed before performing any study related procedures. Training is provided by a sponsor representative to all participating operators
The implantation procedure is performed under ultrasound guidance by a single operator. Local anesthesia, sedation, or general anesthesia may be used at physician and patient discretion. The procedure is performed at the patient’s bedside, in a catheterization laboratory, a surgical suite, or in an outpatient clinic (as approved by the local regulatory authority; in the U.S., the procedure will not be performed in outpatient settings). The time required for inserting the implant in each side of the neck is expected to be less than fifteen (15) minutes. The total implantation procedure will take approximately one hour.
WARNING: The Vine™ system should only be used by trained physicians who are familiar with the clinical risks, benefits, potential complications, side effects, and principles of operation. The operator should be proficient in performing needle-based procedures under ultrasound guidance.
Potential adverse events of the Vine™ implantation procedure include:
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Implant- or procedure-related stroke
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Carotid dissection during implant deployment or retraction
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Bleeding from the puncture site
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Major bleeding related to dual antithrombotic therapy (DAT) at 6 months (single anti-platelet and OAC)
MRI Safety Information
A person with Javelin Medical’s Vine filter may be safely scanned at 1.5T or 3.0T under the following conditions. Failure to follow these conditions may result in injury.
Parameter | Condition |
|---|---|
Device Name | Javelin Medical’s Vine filter |
Static Magnetic Field Strength (B0) | 1.5T and 3T |
MR Scanner Type | Cylindrical |
B0 Field Orientation | Horizontal |
Maximum Spatial Field Gradient | 40 T/m (4,000 G/cm) |
RF Excitation | Circularly Polarized (CP) |
RF Transmit Coil Type | Integrated Whole Body Transmit Coil |
RF Conditions | Normal Operating Mode |
Maximum Whole Body SAR | 2 W/kg |
Maximum Head SAR | 3.2 W/kg |
Scan Duration | Up to 1 hour of continuous scanning without a cooling period |
Scan Regions | Any landmark is acceptable |
Image Artifact | The presence of Javelin Medical’s Vine filter may produce an image artifact of 0.6 cm. Some manipulation of scan parameters may be needed to compensate for the artifact. |
* If information about a specific parameter is not included, there are no conditions associated with that parameter.
MRI Safety Information
Stroke Event During Follow-Up
If a suspected or confirmed stroke occurs after Vine™ filter Implantation, the event is documented and evaluated per study protocol. mRS and EQ-5D-5L assessments are completed 90±7 days after symptom onset (EQ-5D-5L for US/Canada only), and the case is reviewed by the blinded adjudication committee. Patient management and any antithrombotic therapy changes follow local clinical practice.
Thrombectomy
Patients who experience a stroke during the trial will be expected to be treated according to local routine clinical practice. If thrombectomy is being considered, it is important to be aware that crossing the filter with a catheter has not been performed in humans who have received the carotid filter. However, preclinical studies in sheep have demonstrated that a 6F catheter can be passed across the Vine™ filter without deformation. If distortion of the implant occurs, the implant can be restored through snaring catheterization (as observed in animal studies).