Trial Outcomes & Findings for REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent (NCT NCT00631540)

NCT ID: NCT00631540

Last Updated: 2013-12-16

Results Overview

Based on ultrasound images assessed by core lab.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

9 Months

Results posted on

2013-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Formula™ Balloon-Expandable Renal Stent renal artery stenting
Overall Study STARTED	100
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Formula™ Balloon-Expandable Renal Stent renal artery stenting
Overall Study Withdrawal by Subject	5
Overall Study Death	4
Overall Study Lost to Follow-up	2
Overall Study Core Lab Data Unavailable	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Formula™ Balloon-Expandable Renal Stent n=100 Participants renal artery stenting
Age, Continuous	72 Years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Region of Enrollment United States	100 Participants n=5 Participants
Hypertension Hypertension	97 Participants n=5 Participants
Hypertension No Hypertension	3 Participants n=5 Participants
Renal Insufficiency Renal Insufficiency	46 Participants n=5 Participants
Renal Insufficiency No Renal Insufficiency	54 Participants n=5 Participants
Congestive Heart Failure Congestive Heart Failure	26 Participants n=5 Participants
Congestive Heart Failure No Congestive Heart Failure	74 Participants n=5 Participants
Serum Creatinine	1.3 mg/dl STANDARD_DEVIATION 0.5 • n=5 Participants
Estimated Glomerular Filtration Rate	60.7 ml/min STANDARD_DEVIATION 28.8 • n=5 Participants
Systolic Blood Pressure	150.3 mmHg STANDARD_DEVIATION 20.6 • n=5 Participants
Diastolic Blood Pressure	73.9 mmHg STANDARD_DEVIATION 12.9 • n=5 Participants
Number of Antihypertensive Medications per Patient	2.7 Antihypertensive Medications STANDARD_DEVIATION 1.2 • n=5 Participants
Percent Stenosis at Baseline Core Lab	57.4 Percent STANDARD_DEVIATION 13.8 • n=5 Participants
Percent Stenosis at Baseline Site Reported	82.5 Percent STANDARD_DEVIATION 8.1 • n=5 Participants

PRIMARY outcome

Timeframe: 9 Months

Based on ultrasound images assessed by core lab.

Outcome measures

Outcome measures
Measure	Formula™ Balloon-Expandable Renal Stent n=99 Lesions renal artery stenting
Primary Patency of the Treated Renal Artery	91 Lesions

SECONDARY outcome

Timeframe: 30 Days

Population: 1 participant withdrew and 1 participant was lost to follow-up prior to 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.

Outcome measures

Outcome measures
Measure	Formula™ Balloon-Expandable Renal Stent n=98 Participants renal artery stenting
Number of Participants With 30-day Major Adverse Events	0 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: 3 participants withdrew, 4 died, and 1 was lost to follow-up prior to 300 days.

Outcome measures

Outcome measures
Measure	Formula™ Balloon-Expandable Renal Stent n=92 Participants renal artery stenting
Number of Participants With 9-month Major Adverse Events Clinically-driven Target Lesion Revascularization	2 Participants
Number of Participants With 9-month Major Adverse Events Clinical Events Committee (CEC) Adjudicated Death	0 Participants
Number of Participants With 9-month Major Adverse Events CEC Adjudicated Significant Embolic Events	0 Participants
Number of Participants With 9-month Major Adverse Events Clinical Events Committee Adjudicated Q-wave MI	0 Participants

SECONDARY outcome

Timeframe: Prior to Discharge

Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.

Outcome measures

Outcome measures
Measure	Formula™ Balloon-Expandable Renal Stent n=100 Participants renal artery stenting
Technical Success	97 Percentage of Participants

SECONDARY outcome

Timeframe: Prior to Discharge

Population: 1 participant did not have core lab assessment for stenosis.

\< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.

Outcome measures

Outcome measures
Measure	Formula™ Balloon-Expandable Renal Stent n=99 Participants renal artery stenting
Acute Procedural Success	95 Percentage of Participants

SECONDARY outcome

Timeframe: 30 Days

Population: 1 participant was lost to follow-up, 1 participant withdrew, 1 participant did not have core lab assessment.

\< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.

Outcome measures

Outcome measures
Measure	Formula™ Balloon-Expandable Renal Stent n=97 Participants renal artery stenting
30-day Clinical Success	95 Percentage of Participants

Adverse Events

Formula™ Balloon-Expandable Renal Stent

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Formula™ Balloon-Expandable Renal Stent n=99 participants at risk；n=100 participants at risk renal artery stenting
Cardiac disorders Arrhythmias (30 days to 9 months)	6.1% 6/99 • Number of events 7
Cardiac disorders Cardiac Ischemia (30 days to 9 months)	6.1% 6/99 • Number of events 6

Additional Information

Scott Snyder, PhD

Cook Incorporated

Phone: 765-463-7537

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60