Clinical Trial: REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
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.
Detailed Summary:
Sponsor: Cook
Current Primary Outcome: Primary Patency of the Treated Renal Artery [ Time Frame: 9 Months ]
Original Primary Outcome: Primary Patency of the Treated Renal Artery [ Time Frame: 9 Months ]
Current Secondary Outcome:
- 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.
Original Secondary Outcome:
Information By: Cook
Dates:
Date Received: February 28, 2008
Date Started: February 2008
Date Completion:
Last Updated: November 21, 2013
Last Verified: November 2013