Table 2.

Specifications for the pre-procedure fistulogram and the 6-month protocol fistulogram

It will be performed in a dedicated interventional radiology suite equipped with digital subtraction angiogram, image overlay/roadmap post-processing capabilities and ability to capture still and video DICOM file data.

It will be performed through a sheath or cannula placed in the dialysis circuit according to the following specifications:

1. All fistulograms performed as digital subtraction acquisitions at three frames per second

2. The entire access circuit from anastomosis to central vein covered in up to three stages

3. Medial epicondyle of humerus as visible bony landmark on lower arm acquisition; acromioclavicular joint on upper arm and central acquisitions

4. Measurement ruler in view

5. Lower arm acquisition to include:

(a) Anteroposterior projection of anastomosis

(b) Oblique projection of anastomosis (specify oblique and craniocaudal angulation)

6. On the acquisition that best demonstrates the target lesion, the following measurements are made:

(a) Peripheral (close to anastomosis) reference vessel diameter

(b) Minimum lumen diameter (MLD)

(c) Central reference vessel diameter

Specifications for (a) the pre-procedure fistulogram, (b) the 6-month protocol fistulogram, and (c) fistulograms performed for a clinical indication in patients who have: (i) not yet reached the primary endpoint, and (ii) are referred for a potential re-intervention by the radiologist who performed the study treatment and so is not blinded to this