Clinical Trials/NCT00631540

NCT00631540CompletedNot Applicable

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

Cook Group Incorporated7 sites in 1 country100 target enrollmentStarted: February 1, 2008Last updated: December 16, 2013

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Cook Group Incorporated
Enrollment: 100
Locations: 7
Primary Endpoint: Primary Patency of the Treated Renal Artery

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

1

Experimental

renal artery stenting

Intervention: Formula Balloon-Expandable Stent (Device)

Outcomes

Primary Outcomes

Primary Patency of the Treated Renal Artery

Time Frame: 9 Months

Based on ultrasound images assessed by core lab.

Secondary Outcomes

30-day Clinical Success(30 Days)
Number of Participants With 30-day Major Adverse Events(30 Days)
Number of Participants With 9-month Major Adverse Events(9 Months)
Technical Success(Prior to Discharge)
Acute Procedural Success(Prior to Discharge)

Investigators

Sponsor

Cook Group Incorporated

Sponsor Class

Industry

Responsible Party

Sponsor

Study Sites (7)

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