REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent

Cook Group

Status: Completed

Conditions: Renal Artery Stenosis

Treatments: Device: Formula Balloon-Expandable Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631540

06-581

FRUS

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• renal artery stenosis
• appropriate size and location of the lesion
• suboptimal angioplasty

Key Exclusion Criteria:

• less than 18 years old
• failure or inability to give informed consent
• simultaneously participating in another drug or device study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

1

Experimental group

Description:

renal artery stenting

Treatment:

Device: Formula Balloon-Expandable Stent