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