REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
2 other identifiers
interventional
100
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2008
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 28, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedResults Posted
Study results publicly available
May 19, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedDecember 16, 2013
November 1, 2013
2.2 years
February 28, 2008
February 11, 2011
November 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Patency of the Treated Renal Artery
Based on ultrasound images assessed by core lab.
9 Months
Secondary Outcomes (5)
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
30-day Clinical Success
30 Days
Study Arms (1)
1
EXPERIMENTALrenal artery stenting
Interventions
renal artery stenting
Eligibility Criteria
You may qualify if:
- renal artery stenosis
- appropriate size and location of the lesion
- suboptimal angioplasty
You may not qualify if:
- less than 18 years old
- failure or inability to give informed consent
- simultaneously participating in another drug or device study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Munroe Regional Medical Center
Ocala, Florida, 34471, United States
Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Wake Med Raleigh Campus
Raleigh, North Carolina, 27610, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Pinnacle Health at Harrisburg
Harrisburg, Pennsylvania, 17110, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Related Publications (1)
Bersin RM, Ansel G, Rizzo A, Bob Smouse H, Sinha S, Sachar R, Dave R, Weinstock BS, Feldman R, Roubin GS. Nine-month results of the REFORM study: a prospective, single-arm, multicenter clinical study of the safety and effectiveness of the Formula balloon-expandable stent for treatment of renal artery stenosis. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):266-73. doi: 10.1002/ccd.24481. Epub 2013 Mar 25.
PMID: 22581488DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scott Snyder, PhD
- Organization
- Cook Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Bersin, MD
Swedish Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2008
First Posted
March 7, 2008
Study Start
February 1, 2008
Primary Completion
May 1, 2010
Study Completion
May 1, 2012
Last Updated
December 16, 2013
Results First Posted
May 19, 2011
Record last verified: 2013-11