NCT00180544

Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease

A Prospective, Non-Randomized, Multicenter, Single-Arm, Clinical Trial to Assess the Safety and Efficacy of the RX HERCULINK 14 Peripheral Stent System for Treatment in de Novo or Restenotic Renal Artery Stenosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the RX HERCULINK 14 Peripheral Stent System in treating atherosclerotic renal artery stenosis.

Detailed description

A prospective, non-randomized, multi-center, single-arm clinical trial to evaluate the safety and efficacy of the RX HERCULINK™ 14 Peripheral Stent System in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) results in de novo or restenotic atherosclerotic renal artery stenoses.

Conditions

• Renal Artery Obstruction

Interventions

Type	Name	Description
DEVICE	Stenting: Renal Artery	Male and female patients, who meet study eligibility criteria, agree to participate in the trial, and sign an informed consent, will be enrolled in the study. A HERCULINK™ 14 Peripheral Stent will be used in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) atherosclerotic renal artery stenoses.

Timeline

• Start date: 2000-07-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2005-09-16
• Last updated: 2008-07-28

Locations

1 site across 1 country: United States