Catheter-based angiography
Diagnostic TestCatheter-based angiography performed in accordance with the study protocol.
NCT Number: NCT07531966
* 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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Aarhus University Hospital, Aarhus, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Together with at least one of the following radiological criteria:
Before PTA, catheter-based angiography and translesional pressure measurements are performed to confirm whether the patient meets the radiological eligibility criterion for PTA:
Exclusion criteria
Catheter-based angiography performed in accordance with the study protocol.
Measurement of translesional pressure gradients performed in accordance with the study protocol.
Intravascular ultrasound (IVUS) performed in accordance with the study protocol.
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).
Time frame: Baseline and 3 months post-PTA.
Change in measured glomerular filtration rate (mGFR) at 3 months post-PTA compared with baseline.
Time frame: Baseline, Day 1, Day 7, Day 21, 6 weeks, 3 months, 12 months, and annually thereafter for up to 10 years post-PTA.
Change in estimated glomerular filtration rate (eGFR) measured on day 1, day 7, day 21, at 6 weeks, at 3 and 12 months, and annually thereafter for up to 10 years post-PTA, compared with baseline.
Time frame: Baseline, Day 7, Day 21, 6 weeks, 3 months, 12 months, and annually thereafter for up to 10 years post-PTA.
Change in home systolic blood pressure measured on day 7, day 21, at 6 weeks, at 3 and 12 months, and annually thereafter for up to 10 years post-PTA, compared with baseline.
Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.
Change in attended automated office systolic blood pressure measured at 3, 12, and 24 months post-PTA, compared with baseline.
Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.
Change in unattended automated office systolic blood pressure measured at 3, 12, and 24 months post-PTA, compared with baseline.
Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.
Change in 24-hour ambulatory systolic blood pressure measured at 3, 12, and 24 months post-PTA, compared with baseline.
Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.
Change in defined daily dose (DDD) of antihypertensive medications at 3, 12, and 24 months post-PTA compared with baseline.
Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.
Change in the number of antihypertensive medications at 3, 12, and 24 months post-PTA compared with baseline.
Time frame: Baseline, 3 months, 12 months, and 24 months post-PTA.
Change in 24-hour ambulatory systolic blood pressure measured at 3, 12, and 24 months post-PTA, compared with baseline, adjusted for changes in antihypertensive medication (5 mmHg per DDD).
Time frame: Baseline and 3 months post-PTA.
Change in 12-item Short Form Health Survey (SF-12) scores at 3 months post-PTA, compared with baseline.
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame: 10 years post-PTA.
Cardiovascular and renal events are defined according to the criteria used in the DAPA-CKD study, with the modification that end-stage kidney disease is defined exclusively as either kidney transplantation or chronic dialysis. After PTA treatment, the following clinical events will be recorded for 10 years:
Time frame: 30 days post-PTA.
All SAEs, procedure-related adverse events (≤24 hours), and postoperative adverse events (>24 hours) occurring within 30 days after the procedure will be systematically recorded. Events include, but are not limited to:
Time frame: Baseline and 3 months post-PTA.
Diagnostic utility and predictive value for treatment response to PTA.
Time frame: Baseline and 3 months post-PTA.
Diagnostic utility and predictive value for treatment response to PTA.
Time frame: Baseline and 3 months post-PTA.
Diagnostic utility and predictive value for treatment response to PTA.
Time frame: Baseline and 3 months post-PTA.
Diagnostic utility and predictive value for treatment response to PTA.
Time frame: Baseline and 3 months post-PTA.
Diagnostic utility and predictive value for treatment response to PTA.
Contact information is provided by the study sponsor or research team.
Henrik Birn, MD, DMSc
CONTACT
Mark Reinhard, MD, PhD
CONTACT
University of Aarhus
Other
Vascular Complications After Kidney Transplantation: A Prospective National Multicenter Study - The DAN-PTRAIII Study
Acronym: DAN-PTRAIII
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07715734
Advanced Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma (CSCC)
St Louis, Missouri, United States
View Trial DetailsNCT07682350
Kidney Transplant Recipient, Non-Diabetic Patients
Aarhus, Denmark
View Trial DetailsNCT07621835
CMV Reactivation, CMV Specific Immune Response
Córdoba, Spain
View Trial DetailsNCT05975450
Kidney Transplant Recipient
Atlanta, Georgia, United States
View Trial Details