Formula PTX Renal Stent Clinical Study

Cook Group

Status: Completed

Conditions: Renal Artery Stenosis

Treatments: Device: Formula PTX Stent - Dose 2; Device: Formula PTX Stent - Dose 3; Device: Formula PTX Stent - Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057316

06-008

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

Study Group A

Experimental group

Treatment:

Device: Formula PTX Stent - Dose 1

Study Group B

Experimental group

Treatment:

Device: Formula PTX Stent - Dose 2

Study Group C

Experimental group

Treatment:

Device: Formula PTX Stent - Dose 3