In This SectionTexas Health Research & Education Institute
Disease or Condition
Renal Artery Obstruction
A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis (Renal Artery Obstruction / Stent)
The primary objective of this study is to evaluate the safety and effectiveness of the RX Herculink Renal Stent System when used to treat renal artery stenosis (narrowing in the artery). The "renal" artery is the blood vessel that supplies blood to your kidneys. Study subjects will include patients with a diagnosis of uncontrolled hypertension (high blood pressure), defined as systolic blood pressure of 140 mmHg and /or diastolic blood pressure of at least 90 mmHg in the presence of at least two blood pressure medications. Aproximately 202 patients who satisfy or qualify the criteria will be enrolled at up to 50 sites in the Unites States. Patients will have folllow up visits at one, six, nine, 12, 24, and 36 months.
Subject is at least 18 years of age.
Subject is a candidate for renal artery stenting.
Subject has uncontrolled systolic hypertension (systolic BP > or =140 mmHg), or uncontrolled diastolic hypertension (diastolic BP >or =90 mm Hg), or a combination of both in the presence of at least two (2) or more anti-hypertensive medications.
Subject has a baseline serum creatinine of < or = 5mg/dl.
Subject has either unilateral or bilateral de novo or restenotic after PTA (in-stent restenosis excluded) atherosclerotic lesion(s).
Serum creatinine greater than 2.5 mg/dl.
Kidney size less than 8 cm.
Target lesion is in a transplanted kidney or a solitary functioning kidney.
Subject has known allergy or contraindication to clopidogrel (Plavix) or aspirin.
Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.
Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy.