NCT00490841

The HERCULES Trial - A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Renal Artery Obstruction
• Hypertension, Renal

Interventions

Type	Name	Description
DEVICE	Herculink Elite Renal Stent System	This is a prospective, non-randomized, single arm, multi-center study to evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in patients with sub-optimal renal PTA results in de novo or restenotic renal artery lesions. Patients who satisfy the inclusion/exclusion criteria will be enrolled at sites in the United States. Patients will have follow up visits for evaluation.

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-06-01
• Completion: 2012-12-01
• First posted: 2007-06-25
• Last updated: 2012-12-18
• Results posted: 2012-01-30

Locations

1 site across 1 country: United States