REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
|ClinicalTrials.gov Identifier: NCT00631540|
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : May 19, 2011
Last Update Posted : December 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Renal Artery Stenosis||Device: Formula Balloon-Expandable Stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2012|
renal artery stenting
Device: Formula Balloon-Expandable Stent
renal artery stenting
Other Name: renal artery revascularization
- Primary Patency of the Treated Renal Artery [ Time Frame: 9 Months ]Based on ultrasound images assessed by core lab.
- Number of Participants With 30-day Major Adverse Events [ Time Frame: 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 [ Time Frame: 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.
- Technical Success [ Time Frame: Prior to Discharge ]Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.
- Acute Procedural Success [ Time Frame: Prior to Discharge ]< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.
- 30-day Clinical Success [ Time Frame: 30 Days ]< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631540
|United States, Florida|
|Munroe Regional Medical Center|
|Ocala, Florida, United States, 34471|
|Orlando Regional Medical Center|
|Orlando, Florida, United States, 32806|
|United States, New York|
|Lenox Hill Hospital|
|New York, New York, United States, 10075|
|United States, North Carolina|
|Wake Med Raleigh Campus|
|Raleigh, North Carolina, United States, 27610|
|United States, Ohio|
|Fairfield Medical Center|
|Lancaster, Ohio, United States, 43130|
|United States, Pennsylvania|
|Pinnacle Health at Harrisburg|
|Harrisburg, Pennsylvania, United States, 17110|
|United States, Washington|
|Swedish Medical Center|
|Seattle, Washington, United States, 98122|
|Principal Investigator:||Robert Bersin, MD||Swedish Medical Center|