Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting (NCT00640406) | Clinical Trial Compass
CompletedPhase 3
Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting
Germany86 participantsStarted 2008-04
Plain-language summary
The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow ups at 2, 6, 12 months and 3 years.
The purpose of the study is to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the estimated Glomerular Filtration Rate (eGFR) in patients with hemodynamically significant atherosclerotic renal artery stenosis (ARAS).
Who can participate
Age range18 Years
SexALL
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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 revascularizat…
What they're measuring
1
Difference between treatments in change of estimated glomerular filtration rate (eGFR)