Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease
This study has been terminated.
(Device superceded by next generation device. Enrollment stopped, long term follow up was completed in August of 2004.)
Sponsor:
Abbott Vascular
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00180544
First received: September 13, 2005
Last updated: July 24, 2008
Last verified: July 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Artery Obstruction |
Device: Stenting: Renal Artery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Further study details as provided by Abbott Vascular:
Primary Outcome Measures:
- Primary patency . [ Time Frame: at 9-months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Acute procedural success [ Time Frame: Acute ] [ Designated as safety issue: No ]
- Access site events requiring surgical repair or intervention [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
- Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR) [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
- TLR [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: Yes ]
- Changes in blood pressure [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 167 |
| Study Start Date: | July 2000 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Device: 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180544
Locations
| United States, Louisiana | |
| Alton Ochsner Medical Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
Sponsors and Collaborators
Abbott Vascular
Investigators
| Principal Investigator: | Stephen Ramee, M.D. | Alton Ochsner Medical Foundation |
More Information
No publications provided
| Responsible Party: | Maureen Kennedy, Abbott Vascular |
| ClinicalTrials.gov Identifier: | NCT00180544 History of Changes |
| Other Study ID Numbers: | 99-707 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 24, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Renal Artery Obstruction Arterial Occlusive Diseases Kidney Diseases |
Urologic Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013