Clinical Trial: Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 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 Art
Brief 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 Summary: 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.
Sponsor: Abbott Vascular
Current Primary Outcome: Primary patency . [ Time Frame: at 9-months ]
Original Primary Outcome: Primary patency at 9-months.
Current Secondary Outcome:
- Acute procedural success [ Time Frame: Acute ]
- Access site events requiring surgical repair or intervention [ Time Frame: Acute ]
- Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR) [ Time Frame: at 30 days ]
- TLR [ Time Frame: at 9 months ]
- Renal function [ Time Frame: measured at 1, 6, 9, and 12-month follow-up, and every three months thereafter until approximately May 2003 or until patient 169 completes 12 month follow-up. ]
- Changes in blood pressure [ Time Frame: 9 months ]
Original Secondary Outcome:
- Acute success measures
- Access site events requiring surgical repair or intervention
- Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR) at 30 days).
- TLR
- Renal function
- Changes in blood pressure
Information By: Abbott Vascular
Dates:
Date Received: September 13, 2005
Date Started: July 2000
Date Completion:
Last Updated: July 24, 2008
Last Verified: July 2008