Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180544
Status:
TERMINATED
Last Update Posted:
2008-07-28
First Post:
2005-09-13
Brief Title:
Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
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 Artery Stenosis
Status:
TERMINATED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Device superceded by next generation device Enrollment stopped long term follow up was completed in August of 2004
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HERCULINK 14
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None