Status:
COMPLETED
REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
Lead Sponsor:
Cook Group Incorporated
Conditions:
Renal Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Key
- renal artery stenosis
- appropriate size and location of the lesion
- suboptimal angioplasty
- Key
Exclusion
- less than 18 years old
- failure or inability to give informed consent
- simultaneously participating in another drug or device study
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00631540
Start Date
February 1 2008
End Date
May 1 2012
Last Update
December 16 2013
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Munroe Regional Medical Center
Ocala, Florida, United States, 34471
2
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
3
Lenox Hill Hospital
New York, New York, United States, 10075
4
Wake Med Raleigh Campus
Raleigh, North Carolina, United States, 27610