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(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.
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 in patients with less than optimal angioplasty results and uncontrolled hypertension.
Details
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.
Study Type
Interventional
Study Design
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Study Arms
1
Expected Enrollment
202
Study Start
August 2007
Expected Completion
June 2011
Primary Outcome Measures
- Binary restenosis rate as determined by duplex ultrasound within 9 months
Eligibility
Ages Eligible for Study
18 years or older
Genders Eligible for Study
Both
Inclusion Criteria
- Systolic BP >/= 140 mmHg and/or diastolic BP >/= 90 mmHg
- Renal artery stenosis >/= 60%
- Currently taking at least 2 antihypertension medications
- Suboptimal PTA result
Exclusion Criteria
- 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
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