REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00631540
First received: February 28, 2008
Last updated: November 21, 2013
Last verified: November 2013

February 28, 2008
November 21, 2013
February 2008
May 2010   (final data collection date for primary outcome measure)
Primary Patency of the Treated Renal Artery [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
Based on ultrasound images assessed by core lab.
primary patency of the treated renal artery [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00631540 on ClinicalTrials.gov Archive Site
  • Number of Participants With 30-day Major Adverse Events [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.
  • Acute Procedural Success [ Time Frame: Prior to Discharge ] [ Designated as safety issue: No ]
    < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.
  • 30-day Clinical Success [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.
Not Provided
Not Provided
Not Provided
 
REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
Not Provided

The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Artery Stenosis
Device: Formula Balloon-Expandable Stent
renal artery stenting
Other Name: renal artery revascularization
Experimental: 1
renal artery stenting
Intervention: Device: Formula Balloon-Expandable Stent
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2012
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00631540
06-581, FRUS
Yes
Cook
Cook
Not Provided
Principal Investigator: Robert Bersin, MD Swedish Medical Center
Cook
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP