Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting (RADAR)

This is an interventional treatment trial for Renal Artery Stenosis Read More

Inclusion Criteria:

• Age ≥ 18 years
• Informed consent signed by patient (and/or legal guardian),
• Hemodynamically relevant de novo unilateral or bilateral atherosclerotic renal artery diameter stenosis RAS (≥ 70%)
• Estimated GFR > 10 ml/min calculated using the abbreviated Modification of Diet in Renal Disease (MDRD) Study equation,
• Patients presenting mild, moderate or severe hypertension (defined according to the WHO guidelines) and/or renal dysfunction,
• Target lesion must be completely coverable by one study stent,
• Total target lesion length estimated to be less than 19 mm,
• Target lesion accessible to direct stenting or, after pre-dilation, is likely to sufficiently benefit from stenting (at the discretion of the investigator),
• Renal reference vessel diameter (RVD) of ≥ 4.0 mm and < 7.0 mm based on visual estimation,
• Willingness to comply with all the specified follow-up evaluations.

Exclusion Criteria:

• Estimated GFR ≤ 10 ml/min,
• Renal atrophy or kidney length < 7cm (referring to kidney with target lesion),
• Patient not eligible for PTRAS,
• Patient not eligible for stenting,
• Target lesion occlusion,
• Target lesion and/or target vessel proximal to the target lesion is severely calcified,
• Treatment of branch lesion required,
• Fresh thrombus or embolic lesion
• Need for embolic protection in previous or planned PTRAS,
• Clotting disorders,
• INR > 2.5 before the intervention,
• Patient presents fibromuscular dysplasia,
• Prior revascularization of target lesion,
• History of target vessel revascularization within the last six months,
• Angiographic restenosis of any segment of the target vessel that has undergone prior percutaneous intervention,
• Any thrombolytic therapy procedure within 72 hours prior to planned study procedure
• Active peptic ulcer or gastro intestinal bleeding,
• Active inflammation of the kidney interfering with diagnosis and treatment of RAS (e.g. glomerulonephritis, aortitis, vasculitis),
• Radiation damage of the kidney,
• Renal disease associated with aortic aneurysm i.e. diameter of the aorta > 40 mm,
• Chronic renal replacement therapy,
• Life expectancy < 1 year,
• Co-morbid conditions limiting participation and follow-up
• Patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study,
• Pregnancy/Planned pregnancy/Childbearing potential without sufficient measures to prevent pregnancy as judged by the investigator,
• Known allergy to contrast medium that cannot be adequately controlled with pre-medication,
• Known intolerance against acetylic-salicylic acid (ASA), heparin, clopidogrel and ticlopidin, cobalt-chromium,
• Metformin intake not stopped at least 48 hours before the intervention