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

Primary Purpose

Renal Artery Obstruction

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Stenting: Renal Artery
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Artery Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alton Ochsner Medical Foundation

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

Primary patency .

Secondary Outcome Measures

Acute procedural success
Access site events requiring surgical repair or intervention
Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR)
TLR
Renal function
Changes in blood pressure

Full Information

First Posted
September 13, 2005
Last Updated
July 24, 2008
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00180544
Brief Title
Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease
Acronym
HERCULINK 14
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Terminated
Why Stopped
Device superceded by next generation device. Enrollment stopped, long term follow up was completed in August of 2004.
Study Start Date
July 2000 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
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
Intervention Name(s)
Stenting: Renal Artery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary patency .
Time Frame
at 9-months
Secondary Outcome Measure Information:
Title
Acute procedural success
Time Frame
Acute
Title
Access site events requiring surgical repair or intervention
Time Frame
Acute
Title
Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR)
Time Frame
at 30 days
Title
TLR
Time Frame
at 9 months
Title
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.
Title
Changes in blood pressure
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Ramee, M.D.
Organizational Affiliation
Alton Ochsner Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alton Ochsner Medical Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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