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The HERCULES Trial - A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis

NCT00490841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2012-12-18

Study results available
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Summary

The purpose of this study is to determine whether the Herculink Elite Renal Stent System is safe and effective in the treatment of renal artery stenosis in patients with less than optimal angioplasty results and uncontrolled hypertension.

CAUTION: The Herculink Elite Renal Stent System Is An Investigational Device. Limited by Federal (U.S.) Law to Investigational Use Only.

Conditions

  • Renal Artery Obstruction
  • Hypertension, Renal

Interventions

DEVICE

Herculink Elite Renal Stent System

This is a prospective, non-randomized, single arm, multi-center study to evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in patients with sub-optimal renal PTA results in de novo or restenotic renal artery lesions. Patients who satisfy the inclusion/exclusion criteria will be enrolled at sites in the United States. Patients will have follow up visits for evaluation.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Mark Bates, MD · CAMC Health System

  • Stephen Textor, MD · Mayo Clinic

  • Michael Jaff, DO · Vascular Diagnostic Laboratory

  • Timothy Sullivan, MD · Heart Hospital of SD

  • Andrew Blum, MD · Midwest Heart Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-06-30
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00490841 on ClinicalTrials.gov