Inhibition of Neointimal hyperplasia with Paclitaxel-eluting balloon angioplasty in haemodialysis shunts. A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in patients with haemodialysis access stenoses.

Inhibition of Neointimal hyperplasia with Paclitaxel-eluting balloon angioplasty in haemodialysis shunts. A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in patients with haemodialysis access stenoses. - APERTO Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45191

Enrollment

118

Registered

2014-05-01

Start date

2015-05-28

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemodialyse stenosis in dialysis access shunt/fistula

Interventions

PTA of the vessel stenosis, that is, the standard treatment for these patients. The difference between the experimental arm and the control arm is in the use of PTA with paclitaxel DEB versus standa

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects with stenosis in native haemodialysis fistulas or prosthetic haemodialysis grafts on the arm, AND that were previously well functioning, AND that now present with clinical abnormalities indicating decreased functioning, as defined in the NKF-DOQIcprotocol criteria (National Kidney Foundation 2000)

Exclusion criteria

Exclusion criteria: Unable to provide informed consent In-stent restenose (that is: a shunt that has been treated previously with a metallic stent)

Design outcomes

Primary

Measure	Time frame
Primary patency through 6 months defined as absence of haemodialysis access malfunctioning according to the NKF-DOQI-protocol criteria (1996) without clinically driven TLR (reintervention of the target lesion due to insufficient dialysis flow).	—

Secondary

Measure	Time frame
1. Device Success: ability of the DEB to be delivered, inflated at pressure * RBP, and retrieved from the Target Lesion without burst 2. Technical Success: achievement of a lumen diameter of at least 70% of the nominal diameter of either the DEB or the post dilatation PTA balloon (whichever is bigger) by visual estimate and without bail-out stenting 3. Clinical Success: improvement in haemodialysis access failure and resumption of normal dialysis for at least one dialysis session after the index procedure 4. Procedural Success: defined as Technical Success without the occurrence of MAE during the index hospitalization/day of treatment (MAE defined here as: death, stroke, thrombotic occlusion, allergic reaction, pulmonary events (including pulmonary edema) 5. MAE rate through 6 months post index procedure (MAE defined as: death or stroke) 6. Thrombotic occlusion of the Target Lesion through 6 months post index procedure 7. Thrombotic occlusion of the target hemodialysis access (Target Shunt, TS) through 6 months post index procedure 8. Clinically driven Target Lesion Revascularization (TLR) through 6 months post index procedure 9. Clinically driven Target Shunt Revascularization (TSR) through 6 months post index procedure	—

Measure

Time frame

1. Device Success: ability of the DEB to be delivered, inflated at pressure * RBP, and retrieved from the Target Lesion without burst 2. Technical Success: achievement of a lumen diameter of at least 70% of the nominal diameter of either the DEB or the post dilatation PTA balloon (whichever is bigger) by visual estimate and without bail-out stenting 3. Clinical Success: improvement in haemodialysis access failure and resumption of normal dialysis for at least one dialysis session after the index procedure 4. Procedural Success: defined as Technical Success without the occurrence of MAE during the index hospitalization/day of treatment (MAE defined here as: death, stroke, thrombotic occlusion, allergic reaction, pulmonary events (including pulmonary edema) 5. MAE rate through 6 months post index procedure (MAE defined as: death or stroke) 6. Thrombotic occlusion of the Target Lesion through 6 months post index procedure 7. Thrombotic occlusion of the target hemodialysis access (Target Shunt, TS) through 6 months post index procedure 8. Clinically driven Target Lesion Revascularization (TLR) through 6 months post index procedure 9. Clinically driven Target Shunt Revascularization (TSR) through 6 months post index procedure

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)