Vascular Complications After Kidney Transplantation

Summary

* To determine the incidence of arterial inflow problems and venous outflow problems as causes of impaired renal function and/or treatment-resistant hypertension after kidney transplantation, when all kidney-transplant recipients in Denmark are evaluated according to uniform, well-defined clinical criteria.
* To investigate the efficacy and safety of catheter-based balloon treatment (percutaneous transluminal angioplasty, PTA) for these vascular complications, of which transplant renal artery stenosis is by far the most common.
* To assess whether novel imaging and functional diagnostic methods can predict treatment response.

Conditions

• Kidney Transplant Recipient
• Kidney Transplant; Complications
• Transplant Renal Artery Stenosis
• Renovascular Disease
• Renal Transplant Graft Failure
• Renovascular Hypertension
• Heart Failure

Interventions

PROCEDURE

Percutaneous transluminal angioplasty (PTA)

Percutaneous transluminal angioplasty (PTA) is performed in accordance with the study protocol. As a general principle, bare-metal stents (BMS) are used. Drug-eluting stents (DES) may be considered when the arterial lumen diameter is \< 4-5 mm. In stenoses where stent placement carries a risk of side-branch occlusion, PTA is performed without stent implantation and most often with a drug-coated balloon (DCB).

DIAGNOSTIC_TEST

Catheter-based angiography

Catheter-based angiography performed in accordance with the study protocol.

DIAGNOSTIC_TEST

Measurement of translesional pressure gradients

Measurement of translesional pressure gradients performed in accordance with the study protocol.

DIAGNOSTIC_TEST

Intravascular ultrasound (IVUS)

Intravascular ultrasound (IVUS) performed in accordance with the study protocol.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Holbaek Sygehus

  collaborator OTHER

• Amsterdam UMC

  collaborator OTHER

• The Augustinus Foundation, Denmark.

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Mark Reinhard, MD, PhD · Aarhus University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2031-03-31

Completion

2031-03-31

Countries

• Denmark

Study Locations