Skip to main content

Table 1 Inclusion and exclusion criteria for the IMPRESSION study

From: SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial

Inclusion criteria

Exclusion criteria

1. Age 21 to 85 years

2. Patients who require balloon angioplasty for dysfunctional arteriovenous fistula (AVF)

3. Matured AVF, defined as being in use for at least 1 month prior to angioplasty

4. Successful angioplasty of underlying stenosis, defined as less than 30% residual stenosis on digital subtraction angiography based on visual assessment of the operator, and restoration of thrill in the AVF on examination*

1. Patient unable to provide informed consent

2. Thrombosed or partially thrombosed AVF

3. Presence of symptomatic or angiographically significant central vein stenosis who require treatment, with more than 30% residual stenosis post angioplasty

4. Patients who had underwent stent placement within the AVF circuit

5. Patient who are currently enrolled in other drug eluting balloon trials

6. Sepsis or active infection

7. Recent intracranial bleed or gastrointestinal bleed within the past 12 months

8. Allergy to iodinated contrast media, heparin, or sirolimus

9. Pregnancy

  1. *A prominent pulsation felt on palpation of AVF suggesting elevated intra-access pressure caused by an outflow stenosis. This is often accompanied by weak or absence of thrill if the outflow stenosis is severe. Pulsation should disappear or reduced with restoration of thrill in the AVF if angioplasty of the underlying stenosis is successful
Back to article page

Trials

ISSN: 1745-6215