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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.
 
ClinicalTrials.gov Identifier: NCT00631540
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : May 19, 2011
Last Update Posted : December 16, 2013
Sponsor:
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
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Formula™ Balloon-Expandable Renal Stent
Hide Arm/Group Description renal artery stenting
Period Title: Overall Study
Started 100
Completed 86
Not Completed 14
Reason Not Completed
Withdrawal by Subject             5
Death             4
Lost to Follow-up             2
Core Lab Data Unavailable             3
Arm/Group Title Formula™ Balloon-Expandable Renal Stent
Hide Arm/Group Description renal artery stenting
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
72  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
56
  56.0%
Male
44
  44.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants
100
Hypertension   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
Hypertension 97
No Hypertension 3
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
Renal Insufficiency 46
No Renal Insufficiency 54
[1]
Measure Description: Renal Insufficiency was defined by the physician, based on the patient's medical history.
Congestive Heart Failure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
Congestive Heart Failure 26
No Congestive Heart Failure 74
Serum Creatinine  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 100 participants
1.3  (0.5)
Estimated Glomerular Filtration Rate  
Mean (Standard Deviation)
Unit of measure:  Ml/min
Number Analyzed 100 participants
60.7  (28.8)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 100 participants
150.3  (20.6)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 100 participants
73.9  (12.9)
Number of Antihypertensive Medications per Patient  
Mean (Standard Deviation)
Unit of measure:  Antihypertensive Medications
Number Analyzed 100 participants
2.7  (1.2)
Percent Stenosis at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 100 participants
Core Lab 57.4  (13.8)
Site Reported 82.5  (8.1)
[1]
Measure Description: Baseline stenosis was determined by angiography.
1.Primary Outcome
Title Primary Patency of the Treated Renal Artery
Hide Description Based on ultrasound images assessed by core lab.
Time Frame 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Formula™ Balloon-Expandable Renal Stent
Hide Arm/Group Description:
renal artery stenting
Overall Number of Participants Analyzed 86
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
99
Measure Type: Number
Unit of Measure: Lesions
91
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Formula™ Balloon-Expandable Renal Stent
Comments Alternative hypothesis is 9-month primary patency rate greater than 60%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Z-test, 1-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Patency Rate
Estimated Value 91.7
Confidence Interval (2-Sided) 95%
84.2 to 95.9
Estimation Comments GEE model estimate.
2.Secondary Outcome
Title Number of Participants With 30-day Major Adverse Events
Hide Description Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant withdrew and 1 participant was lost to follow-up prior to 30 days.
Arm/Group Title Formula™ Balloon-Expandable Renal Stent
Hide Arm/Group Description:
renal artery stenting
Overall Number of Participants Analyzed 98
Measure Type: Number
Unit of Measure: Participants
0
3.Secondary Outcome
Title Number of Participants With 9-month Major Adverse Events
Hide Description Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Time Frame 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
3 participants withdrew, 4 died, and 1 was lost to follow-up prior to 300 days.
Arm/Group Title Formula™ Balloon-Expandable Renal Stent
Hide Arm/Group Description:
renal artery stenting
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Participants
Clinically-driven Target Lesion Revascularization 2
Clinical Events Committee (CEC) Adjudicated Death 0
CEC Adjudicated Significant Embolic Events 0
Clinical Events Committee Adjudicated Q-wave MI 0
4.Secondary Outcome
Title Technical Success
Hide Description Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.
Time Frame Prior to Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Formula™ Balloon-Expandable Renal Stent
Hide Arm/Group Description:
renal artery stenting
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: Percentage of Participants
97
5.Secondary Outcome
Title Acute Procedural Success
Hide Description < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.
Time Frame Prior to Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant did not have core lab assessment for stenosis.
Arm/Group Title Formula™ Balloon-Expandable Renal Stent
Hide Arm/Group Description:
renal artery stenting
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: Percentage of Participants
95
6.Secondary Outcome
Title 30-day Clinical Success
Hide Description < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant was lost to follow-up, 1 participant withdrew, 1 participant did not have core lab assessment.
Arm/Group Title Formula™ Balloon-Expandable Renal Stent
Hide Arm/Group Description:
renal artery stenting
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Percentage of Participants
95
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Formula™ Balloon-Expandable Renal Stent
Hide Arm/Group Description renal artery stenting
All-Cause Mortality
Formula™ Balloon-Expandable Renal Stent
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Formula™ Balloon-Expandable Renal Stent
Affected / at Risk (%) # Events
Total   0/100 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Formula™ Balloon-Expandable Renal Stent
Affected / at Risk (%) # Events
Total   11/99 (11.11%)    
Cardiac disorders   
Arrhythmias (30 days to 9 months) [1]  6/99 (6.06%)  7
Cardiac Ischemia (30 days to 9 months) [2]  6/99 (6.06%)  6
[1]
1 participant withdrew, 1 participant was lost to follow-up who experienced adverse events but were not reported here due to < 5%
[2]
1 participant withdrew, 1 participant was lost to follow-up who experienced adverse events but was not reported here due to < 5%
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott Snyder, PhD
Organization: Cook Incorporated
Phone: 765-463-7537
EMail: ssnyder@medinst.com
Layout table for additonal information
Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00631540    
Other Study ID Numbers: 06-581
FRUS
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