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

Not Applicable

Completed

• Conditions: Renal Artery Stenosis
• Interventions: Device: Formula Balloon-Expandable Stent

• Registration Number: NCT00631540
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Primary Completion: 2010-05
• Results First Submitted: 2011-02-11
• Results First Submitted QC: 2011-04-20
• Results First Posted: 2011-05-19
• Study Completion: 2012-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Formula Balloon-Expandable Stent	renal artery stenting

Primary Outcome Measures

Name	Time	Method
Primary Patency of the Treated Renal Artery	9 Months	Based on ultrasound images assessed by core lab.

Secondary Outcome Measures

Name	Time	Method
Technical Success	Prior to Discharge	Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.
30-day Clinical Success	30 Days	\< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.
Number of Participants With 30-day Major Adverse Events	30 Days	Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Number of Participants With 9-month Major Adverse Events	9 Months	Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Acute Procedural Success	Prior to Discharge	\< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.

Trial Locations

Locations (7)

Fairfield Medical Center; 🇺🇸 Lancaster, Ohio, United States

Munroe Regional Medical Center; 🇺🇸 Ocala, Florida, United States

Wake Med Raleigh Campus; 🇺🇸 Raleigh, North Carolina, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Orlando Regional Medical Center; 🇺🇸 Orlando, Florida, United States

Pinnacle Health at Harrisburg; 🇺🇸 Harrisburg, Pennsylvania, United States