Renal Artery Disease - HERCULES

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Trial Sponsor
Abbott Vascular

Principal Investigator
Gregory Mishkel, MD

Trial Name
A Clinical Trial to Assess the Safety and Efficacy of the RX Herculink® Elite(™ 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.

Purpose
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 (blockages in the kidney arteries) in patients with uncontrolled hypertension (high blood pressure).

Details
This trial has been designed to look at the safety and effectiveness of the RX Herculink Elite Renal Stent System for treatment of patients with uncontrolled hypertension or high blood pressure that do not get a good result from ballooning of the kidney artery due to a narrowing or blockage in the artery. This trial will also continue to look at the relationship between kidney artery narrowing/blockages and the affect on a patient’s blood pressure.

Ages Eligible for Study
18 years or older

Genders Eligible for Study
Both

Inclusion Criteria

• Patients with a blood pressure that is greater or equal to 140/90
• Subjects that have been found to have a 60% or greater narrowing in their kidney (renal) artery by their physician.
• Subjects that are currently taking at least 2 anti-hypertension medications.

Exclusion Criteria

• Subject with poor kidney function as determined by their physician.
• Subjects with small kidneys as determined by their physician
• Subjects that have a solitary kidney or that have undergone a kidney transplant.

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