Study Stopped
Device superceded by next generation device. Enrollment stopped, long term follow up was completed in August of 2004.
Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease
HERCULINK 14
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
1 other identifier
interventional
167
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2000
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedJuly 28, 2008
July 1, 2008
4.1 years
September 13, 2005
July 24, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Primary patency .
at 9-months
Secondary Outcomes (6)
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.
- +1 more secondary outcomes
Study Arms (1)
1
OTHERMale 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
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of renal artery atherosclerosis; candidate for renal artery angioplasty and stenting; blood pressure \>160/90
You may not qualify if:
- Totally occluded renal artery on the opposite side; only one functioning kidney; target lesion is in a transplanted kidney; renal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alton Ochsner Medical Foundation
New Orleans, Louisiana, 70121, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Ramee, M.D.
Alton Ochsner Medical Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
July 1, 2000
Primary Completion
August 1, 2004
Study Completion
August 1, 2004
Last Updated
July 28, 2008
Record last verified: 2008-07