Phase
Condition
Diabetes And Hypertension
Heart Failure
Congestive Heart Failure
Treatment
Measurement of translesional pressure gradients
Intravascular ultrasound (IVUS)
Catheter-based angiography
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 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.
- 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:
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 theoperator's clinical judgement.
Exclusion
Exclusion Criteria:
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 noteligible for stent placement.
Study Design
Study Description
Connect with a study center
Aarhus University Hospital
Aarhus, 8200
DenmarkActive - Recruiting
Rigshospitalet
Copenhagen, 2100
DenmarkActive - Recruiting
Odense University Hospital
Odense, 5000
DenmarkActive - Recruiting

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.