NCT07531966Recruiting
Vascular Complications After Kidney Transplantation
Vascular Complications After Kidney Transplantation: A Prospective National Multicenter Study - The DAN-PTRAIII Study
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
* 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 1 Apr 2026
- Start date
- 22 May 2026
- Primary completion date
- 31 Mar 2031
- Lead sponsor
- University of Aarhus
- Diseases
- Heart failure, High blood pressure
- NCT number
- NCT07531966
What you commit to
- Study type: Observational
- Planned participants: 60
- From 22 May 2026 to the primary completion date, 31 Mar 2031
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent biopsy demonstrating rejection requiring treatment.
- Previous PTA of the same vessel.
- Patients unable to tolerate any form of antithrombotic therapy and therefore not eligible for stent placement.
Other
- Inability to provide informed consent.
- Pregnancy.
Who the study is looking for
- 1\. 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:
- 24-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.
- 2\. 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.