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

NCT ID: NCT00180544

Last Updated: 2008-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2004-08-31

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.

Conditions

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Renal Artery Obstruction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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.

Group Type OTHER

Stenting: Renal Artery

Intervention Type DEVICE

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.

Interventions

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Stenting: Renal Artery

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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott Vascular

Principal Investigators

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Stephen Ramee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Alton Ochsner Medical Foundation

Locations

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Alton Ochsner Medical Foundation

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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99-707

Identifier Type: -

Identifier Source: org_study_id