Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease
Phase 3
Terminated
- Conditions
- Renal Artery Obstruction
- Registration Number
- NCT00180544
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 167
Inclusion Criteria
- Clinical diagnosis of renal artery atherosclerosis; candidate for renal artery angioplasty and stenting; blood pressure >160/90
Exclusion Criteria
- Totally occluded renal artery on the opposite side; only one functioning kidney; target lesion is in a transplanted kidney; renal insufficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary patency . at 9-months
- Secondary Outcome Measures
Name Time Method Acute procedural success Acute Access site events requiring surgical repair or intervention Acute Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR) at 30 days TLR at 9 months Renal function 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 9 months
Trial Locations
- Locations (1)
Alton Ochsner Medical Foundation
🇺🇸New Orleans, Louisiana, United States