Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hyper… (NCT01673373) | Clinical Trial Compass
CompletedNot Applicable
Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension
United States68 participantsStarted 2012-10-23
Plain-language summary
The purpose of this trial is to test how well the iCASTâ„¢ RX Stent works in patients diagnosed with atherosclerotic renal artery stenosis and whether or not increased blood flow by the stent will help to control blood pressure.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 at the time of informed consent.
✓. Subject or subject's legal representative have been informed of the nature of the trial, agrees to participate, and has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF).
✓. Subjects that have bilateral kidneys or a solitary functioning kidney with Renal Artery Stenosis in at least one kidney and an average Systolic Blood Pressure (SBP) ≥ 155mmHg.
✓. Subject has a history of maximum tolerable dose of ≥ 3 anti-hypertensive medications of different classes, one of which must be a diuretic (for at least two weeks prior to Medical Documentation Screening period).
✓. Subject must have documented clinical evidence to support likelihood of angiographic findings \> 80% whether it is DUS, CTa, MRa or other medical evidence.
✓. New York Heart Association (NYHA) class I, II, or III the time of trial enrollment.