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(Device superceded by next generation device.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:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00180544
First received: September 13, 2005
Last updated: July 24, 2008
Last verified: July 2008
  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 April 17, 2014