Hypertension, Renal Clinical Trial
Official title:
A Clinical Trial to Assess the Safety and Efficacy of the RX Herculink(R) Elite(TM) Renal Stent System for the Treatment of Suboptimal Post-procedural Percutaneous Transluminal Angioplasty (PTA) in de Novo or Restenotic Renal Artery Stenoses in Patients With Uncontrolled Hypertension.
The purpose of this study is to determine whether the Herculink Elite Renal Stent System is
safe and effective in the treatment of renal artery stenosis in patients with less than
optimal angioplasty results and uncontrolled hypertension.
CAUTION: The Herculink Elite Renal Stent System Is An Investigational Device. Limited by
Federal (U.S.) Law to Investigational Use Only.
To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the
treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of
atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled
hypertension.
CAUTION: The Herculink Elite Renal Stent System Is An Investigational Device. Limited by
Federal (U.S.) Law to Investigational Use Only.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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