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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00631540
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : May 19, 2011
Last Update Posted : December 16, 2013
Information provided by (Responsible Party):
Cook Group Incorporated

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Renal Artery Stenosis
Intervention: Device: Formula Balloon-Expandable Stent

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Formula™ Balloon-Expandable Renal Stent renal artery stenting

Participant Flow:   Overall Study
    Formula™ Balloon-Expandable Renal Stent
STARTED   100 
Withdrawal by Subject                5 
Death                4 
Lost to Follow-up                2 
Core Lab Data Unavailable                3 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Formula™ Balloon-Expandable Renal Stent renal artery stenting

Baseline Measures
   Formula™ Balloon-Expandable Renal Stent 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 72  (10) 
[Units: Participants]
Female   56 
Male   44 
Region of Enrollment 
[Units: Participants]
United States   100 
Hypertension [1] 
[Units: Participants]
Hypertension   97 
No Hypertension   3 
[1] Pre-hypertension: Systolic 120-139 mmHg, Diastolic 80-89 mmHg Stage 1: Systolic 140-159 mmHg, Diastolic 90-99 mmHg Stage 2: Systolic >160 mmHg, Diastolic > 100 mmHg If systolic and diastolic pressures were in different categories, the higher category was chosen.
Renal Insufficiency [1] 
[Units: Participants]
Renal Insufficiency   46 
No Renal Insufficiency   54 
[1] Renal Insufficiency was defined by the physician, based on the patient's medical history.
Congestive Heart Failure 
[Units: Participants]
Congestive Heart Failure   26 
No Congestive Heart Failure   74 
Serum Creatinine 
[Units: Mg/dl]
Mean (Standard Deviation)
 1.3  (0.5) 
Estimated Glomerular Filtration Rate 
[Units: Ml/min]
Mean (Standard Deviation)
 60.7  (28.8) 
Systolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 150.3  (20.6) 
Diastolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 73.9  (12.9) 
Number of Antihypertensive Medications per Patient 
[Units: Antihypertensive Medications]
Mean (Standard Deviation)
 2.7  (1.2) 
Percent Stenosis at Baseline [1] 
[Units: Percent]
Mean (Standard Deviation)
Core Lab   57.4  (13.8) 
Site Reported   82.5  (8.1) 
[1] Baseline stenosis was determined by angiography.

  Outcome Measures

1.  Primary:   Primary Patency of the Treated Renal Artery   [ Time Frame: 9 Months ]

2.  Secondary:   Number of Participants With 30-day Major Adverse Events   [ Time Frame: 30 Days ]

3.  Secondary:   Number of Participants With 9-month Major Adverse Events   [ Time Frame: 9 Months ]

4.  Secondary:   Technical Success   [ Time Frame: Prior to Discharge ]

5.  Secondary:   Acute Procedural Success   [ Time Frame: Prior to Discharge ]

6.  Secondary:   30-day Clinical Success   [ Time Frame: 30 Days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Scott Snyder, PhD
Organization: Cook Incorporated
phone: 765-463-7537

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Cook Group Incorporated Identifier: NCT00631540     History of Changes
Other Study ID Numbers: 06-581
First Submitted: February 28, 2008
First Posted: March 7, 2008
Results First Submitted: February 11, 2011
Results First Posted: May 19, 2011
Last Update Posted: December 16, 2013