Status:
COMPLETED
Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting
Lead Sponsor:
Biotronik AG
Conditions:
Renal Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00640406
Start Date
April 1 2008
End Date
March 1 2015
Last Update
July 21 2015
Active Locations (1)
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1
Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany, 79189