Formula PTX Renal Stent Clinical Study

Cook Group Incorporated120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Renal Artery Stenosis

Interventions

Formula PTX Stent - Dose 1DEVICE

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

Formula PTX Stent - Dose 2DEVICE

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

Formula PTX Stent - Dose 3DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

University Hospital Ostrava

Ostrava-Poruba, Czechia

Institute for Clinical and Experimental Medicine

Prague, Czechia

Hopital Europeen Georges Pomidou

Paris, France

Outcomes

Primary Outcomes

Percent Diameter Stenosis of the Treated Renal Artery

Time frame: 9 months

Data from ClinicalTrials.gov

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