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

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ClinicalTrials.gov Identifier: NCT00180544
Recruitment Status : Terminated (Device superceded by next generation device. Enrollment stopped, long term follow up was completed in August of 2004.)
First Posted : September 16, 2005
Last Update Posted : July 28, 2008
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Renal Artery Obstruction Device: Stenting: Renal Artery Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2000
Primary Completion Date : August 2004
Study Completion Date : August 2004
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Primary patency . [ Time Frame: at 9-months ]

Secondary Outcome Measures :
  1. Acute procedural success [ Time Frame: Acute ]
  2. Access site events requiring surgical repair or intervention [ Time Frame: Acute ]
  3. Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR) [ Time Frame: at 30 days ]
  4. TLR [ Time Frame: at 9 months ]
  5. 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. ]
  6. Changes in blood pressure [ Time Frame: 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Maureen Kennedy, Abbott Vascular
ClinicalTrials.gov Identifier: NCT00180544     History of Changes
Other Study ID Numbers: 99-707
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 28, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Renal Artery Obstruction
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases