RecruitingNCT07531966

Vascular Complications After Kidney Transplantation

Vascular Complications After Kidney Transplantation: A Prospective National Multicenter Study - The DAN-PTRAIII Study


Sponsor

University of Aarhus

Enrollment

60 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria20

  • \. At least one of the following clinical criteria (1 or 2) must be fulfilled:
  • Graft dysfunction, defined by at least one of the following:
  • Acute reduction in estimated glomerular filtration rate (eGFR) >15% on two consecutive measurements at least 2 weeks apart, with other causes excluded (rejection, obstruction, infection).
  • eGFR <50% of the expected value 30 days after kidney transplantation of unknown cause.
  • Decline in eGFR >30% after initiation of an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker.
  • Persistent resistant hypertension for more than 6 weeks after kidney transplantation, defined as:
  • -hour ambulatory systolic blood pressure >130 mmHg despite treatment with at least three classes of antihypertensive medication at maximally tolerated doses (including diuretics, if tolerated).
  • Together with at least one of the following radiological criteria:
  • CT or MR angiography demonstrating a lumen reduction ≥50%.
  • Doppler ultrasound showing:
  • Peak systolic velocity in the renal artery ≥200 cm/s and a renal renal ratio (velocity at stenosis / velocity in distal artery) >4.
  • Acceleration time >70 ms in intrarenal arteries.
  • \. In cases of strong clinical suspicion of a vascular complication where CT or MR angiography cannot reliably exclude graft artery or vein stenosis, patients may be referred for confirmatory invasive investigations.
  • Before PTA, catheter-based angiography and translesional pressure measurements are performed to confirm whether the patient meets the radiological eligibility criterion for PTA:
  • Stenosis ≥70%.
  • Stenosis 50-69% if at least one of the following criteria is met:
  • Mean translesional pressure gradient ≥10 mmHg.
  • Systolic pressure gradient ≥20 mmHg.
  • Renal Pd/Pa ≤0.8.
  • If pressure measurements cannot be obtained, treatment is based on the operator's clinical judgement.

Exclusion Criteria5

  • Inability to provide informed consent.
  • Concurrent biopsy demonstrating rejection requiring treatment.
  • Pregnancy.
  • Previous PTA of the same vessel.
  • Patients unable to tolerate any form of antithrombotic therapy and therefore not eligible for stent placement.

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Interventions

DIAGNOSTIC_TESTCatheter-based angiography

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

DIAGNOSTIC_TESTMeasurement of translesional pressure gradients

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

DIAGNOSTIC_TESTIntravascular ultrasound (IVUS)

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

PROCEDUREPercutaneous 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).


Locations(3)

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

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NCT07531966


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