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
Results First Received: February 11, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Artery Stenosis
Intervention: Device: Formula Balloon-Expandable Stent

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Description
Formula™ Balloon-Expandable Renal Stent renal artery stenting

Participant Flow:   Overall Study
    Formula™ Balloon-Expandable Renal Stent  
STARTED     100  
COMPLETED     86  
NOT COMPLETED     14  
Withdrawal by Subject                 5  
Death                 4  
Lost to Follow-up                 2  
Core Lab Data Unavailable                 3  



  Baseline Characteristics
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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
  Description
Formula™ Balloon-Expandable Renal Stent renal artery stenting

Baseline Measures
    Formula™ Balloon-Expandable Renal Stent  
Number of Participants  
[units: participants]
  100  
Age  
[units: Years]
Mean ± Standard Deviation
  72  ± 10  
Gender  
[units: Participants]
 
Female     56  
Male     44  
Region of Enrollment  
[units: Participants]
 
United States     100  
Hypertension [1]
[units: Participants]
 
Hypertension     97  
No Hypertension     3  
Renal Insufficiency [2]
[units: Participants]
 
Renal Insufficiency     46  
No Renal Insufficiency     54  
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┬áMedications]
Mean ± Standard Deviation
  2.7  ± 1.2  
Percent Stenosis at Baseline [3]
[units: Percent]
Mean ± Standard Deviation
 
Core Lab     57.4  ± 13.8  
Site Reported     82.5  ± 8.1  
[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.
[2] Renal Insufficiency was defined by the physician, based on the patient's medical history.
[3] Baseline stenosis was determined by angiography.



  Outcome Measures
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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


  More Information
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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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Scott Snyder, PhD
Organization: Cook Incorporated
phone: 765-463-7537
e-mail: ssnyder@medinst.com


No publications provided by Cook

Publications automatically indexed to this study:

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00631540     History of Changes
Other Study ID Numbers: 06-581, FRUS
Study First Received: February 28, 2008
Results First Received: February 11, 2011
Last Updated: November 21, 2013
Health Authority: United States: Food and Drug Administration