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
About this trial
This is an interventional treatment trial for Renal Artery Obstruction
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
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
NCT ID
NCT00180544
First Posted
September 13, 2005
Last Updated
July 24, 2008
Sponsor
Abbott Medical Devices
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Device superceded by next generation device.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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