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

Renal Artery Stenosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631540
• Other study ID #: 06-581
• Secondary ID: FRUS
• Status: Completed
• Phase: N/A
• First received: February 28, 2008
• Last updated: November 21, 2013
• Start date: February 2008
• Est. completion date: May 2012

Study information

• Verified date: November 2013
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

Device:
• Formula Balloon-Expandable Stent
renal artery stenting

Locations

Country	Name	City	State
United States	Pinnacle Health at Harrisburg	Harrisburg	Pennsylvania
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Lenox Hill Hospital	New York	New York
United States	Munroe Regional Medical Center	Ocala	Florida
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Wake Med Raleigh Campus	Raleigh	North Carolina
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency of the Treated Renal Artery	Based on ultrasound images assessed by core lab.	9 Months	No
Secondary	Number of Participants With 30-day Major Adverse Events	Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.	30 Days	Yes
Secondary	Number of Participants With 9-month Major Adverse Events	Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.	9 Months	Yes
Secondary	Technical Success	Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.	Prior to Discharge	No
Secondary	Acute Procedural Success	< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.	Prior to Discharge	No
Secondary	30-day Clinical Success	< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.	30 Days	No