REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|