Renal Artery Stenosis
Conditions
Brief 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.
Interventions
DEVICEFormula PTX Stent - Dose 1
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
DEVICEFormula PTX Stent - Dose 2
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
DEVICEFormula PTX Stent - Dose 3
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Diameter Stenosis of the Treated Renal Artery | 9 months |
Countries
Czechia, France, Germany, United Kingdom
Outcome results
None listed