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Formula PTX Renal Stent Clinical Study

NCT01057316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-06-01

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.

Conditions

  • Renal Artery Stenosis

Interventions

DEVICE

Formula PTX Stent - Dose 1

Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.

DEVICE

Formula PTX Stent - Dose 2

Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.

DEVICE

Formula PTX Stent - Dose 3

Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.

Sponsors & Collaborators

  • Cook Group Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-01-31
Completion
2018-04-09

Countries

  • Czechia
  • France
  • Germany
  • United Kingdom

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 NCT01057316 on ClinicalTrials.gov