Overview

This trial is active, not recruiting.

Condition renal artery stenosis
Treatments formula ptx stent - dose 1, formula ptx stent - dose 2, formula ptx stent - dose 3
Sponsor Cook
Start date February 2010
End date January 2014
Trial size 120 participants
Trial identifier NCT01057316, 06-008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
formula ptx stent - dose 1
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
(Experimental)
formula ptx stent - dose 2
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
(Experimental)
formula ptx stent - dose 3
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.

Primary Outcomes

Measure
Percent Diameter Stenosis of the Treated Renal Artery
time frame: 9 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - renal artery stenosis - appropriate size and location of the lesion Exclusion Criteria: - pregnant or breast feeding - failure or inability to give informed consent - simultaneously participating in another drug or device study

Additional Information

Official title Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Cook.