N/A
Completed N=100
REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
Renal Artery Stenosis
Source: ClinicalTrials.gov NCT00631540 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Primary Patency of the Treated Renal Artery — 91 Lesions — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Patency of the Treated Renal Artery |
91 | <0.0001 sig |
| SECONDARY Number of Participants With 30-day Major Adverse Events |
— | — |
| SECONDARY Number of Participants With 9-month Major Adverse Events |
2; 0; 0; 0 | — |
| SECONDARY Technical Success |
97 | — |
| SECONDARY Acute Procedural Success |
95 | — |
| SECONDARY 30-day Clinical Success |
95 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00631540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.