💬In plain words
What the trial is, and whether it could suit you
* 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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1\. At least one of the following clinical criteria (1 or 2) must be fulfilled:
1. 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.
2. 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:
1. CT or MR angiography demonstrating a lumen reduction ≥50%.
2. Doppler ultrasound showing:
1. Peak systolic velocity in the renal artery ≥200 cm/s and a renal-renal ratio (velocity at stenosis / velocity in distal artery) \>4.
2. 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:
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 the operator's clinical judgement.
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 not eligible for stent placement.
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