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 ]

Based on ultrasound images assessed by core lab.


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