CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 202 enrolled
Drug / intervention
Herculink Elite Renal Stent Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00490841
NCT00490841N/ACompleted
CompareCT.gov

A Clinical Trial to Assess the Safety and Efficacy of the RX Herculink(R) Elite(TM) Renal Stent System for the Treatment of Suboptimal Post-procedural Percutaneous Transluminal Angioplasty (PTA) in de Novo or Restenotic Renal Artery Stenoses in Patients With Uncontrolled Hypertension.

Abbott Medical Devices·interventional·Posted Jun 25, 2007·Updated Dec 18, 2012

In Brief

A clinical study evaluating Herculink Elite Renal Stent System for Renal Artery Obstruction and Hypertension, Renal. Completed, enrolled 202 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Artery Obstruction, Hypertension, Renal
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2007
Enrollment StartAug 1, 2007
Primary CompletionJun 1, 2010
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.0 years ago

Interventions

Herculink Elite Renal Stent Systemdevice

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.