Vascular Complications After Kidney Transplantation

Last updated: May 26, 2026
Sponsor: University of Aarhus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Heart Failure

Congestive Heart Failure

Treatment

Measurement of translesional pressure gradients

Intravascular ultrasound (IVUS)

Catheter-based angiography

Clinical Study ID

NCT07531966
DAN-PTRAIII
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. At least one of the following clinical criteria (1 or 2) must be fulfilled:

  2. Graft dysfunction, defined by at least one of the following:

  • Acute reduction in estimated glomerular filtration rate (eGFR) >15% on twoconsecutive 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 unknowncause.

  • Decline in eGFR >30% after initiation of an angiotensin-converting enzymeinhibitor or angiotensin II receptor blocker.

  1. Persistent resistant hypertension for more than 6 weeks after kidneytransplantation, defined as:
  • 24-hour ambulatory systolic blood pressure >130 mmHg despite treatment with atleast three classes of antihypertensive medication at maximally tolerated doses (including diuretics, if tolerated).

Together with at least one of the following radiological criteria:

  1. CT or MR angiography demonstrating a lumen reduction ≥50%.

  2. Doppler ultrasound showing:

  3. Peak systolic velocity in the renal artery ≥200 cm/s and a renal renal ratio (velocity at stenosis / velocity in distal artery) >4.

  4. Acceleration time >70 ms in intrarenal arteries.

  5. 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:

  1. Stenosis ≥70%.

  2. 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 theoperator's clinical judgement.

Exclusion

Exclusion Criteria:

  1. Inability to provide informed consent.

  2. Concurrent biopsy demonstrating rejection requiring treatment.

  3. Pregnancy.

  4. Previous PTA of the same vessel.

  5. Patients unable to tolerate any form of antithrombotic therapy and therefore noteligible for stent placement.

Study Design

Total Participants: 60
Treatment Group(s): 4
Primary Treatment: Measurement of translesional pressure gradients
Phase:
Study Start date:
May 22, 2026
Estimated Completion Date:
June 01, 2031

Study Description

Kidney transplantation is performed 250-300 times annually in Denmark and substantially improves survival, quality of life, and reduces the burden of comorbidities in patients with end-stage kidney disease. Despite these benefits, vascular complications, particularly transplant renal artery stenosis (TRAS), remain a major cause of morbidity. Reported incidence of TRAS varies widely (1-23%), reflecting retrospective study designs and inconsistent diagnostic criteria. TRAS are classified into three main types: anastomotic (TRAS-A), post-anastomotic (TRAS-P), and long-segment bend/kink (TRAS-B), with most cases diagnosed within the first two years post-transplant. Severe stenoses can critically impair graft perfusion, leading to reduced renal function and treatment-resistant hypertension.

Percutaneous transluminal angioplasty (PTA) for TRAS is a well-established procedure performed according to the same principles as coronary balloon angioplasty; however, the role of stent placement remains uncertain. PTA without stenting is associated with higher restenosis rates compared to PTA with stenting, yet evidence regarding graft function, survival, and blood-pressure control remains conflicting.

Adverse events related to PTA occur in approximately 10% of patients and are generally mild. Serious adverse events are observed in fewer than 5% of patients and include procedure-related internal bleeding and vascular access-site complications. Severe internal bleeding may require blood transfusion and endovascular vessel occlusion and can, in rare cases, result in loss of the transplanted kidney. Access-site vascular complications may present as bleeding, thrombosis, or pseudoaneurysm.

Against this background, the nationwide prospective multicentre DAN-PTRAIII study aims to establish the true incidence of arterial inflow and venous outflow problems in Danish kidney-transplant recipients, evaluate the efficacy and safety of balloon angioplasty, and explore novel imaging and functional diagnostic methods for predicting treatment response.

Connect with a study center

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense, 5000
    Denmark

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.