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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Renal Artery Obstruction

Intervention / Treatment
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* Device: Stenting: Renal Artery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>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. | Device: Stenting: Renal Artery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency . |  | at 9-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |