Trial Outcomes & Findings for Cutting Balloon Study (NCT NCT01205568)
NCT ID: NCT01205568
Last Updated: 2018-05-25
Results Overview
The primary efficacy outcome is the percent change in minimum lumen diameter from pre-intervention to immediately post-intervention as measured by angiography.
COMPLETED
NA
73 participants
Pre-intervention to immediate post-intervention (approximately 10 minutes)
2018-05-25
Participant Flow
Among 73 patients, 331 stenotic vessels were identified. 86 vessels were not eligible and 245 vessels were potentially eligible. 72 vessels were considered successfully treated after low-pressure dilation. 173 met eligibility. 66 vessels were randomized to High Pressure Balloon (HPB) and 107 vessels were randomized to Cutting Balloon (CB).
Unit of analysis: Vessels
Participant milestones
| Measure |
Cutting Balloon (CB)
Resistant Vessels with Pulmonary Artery Stenosis were identified during catheterization and vessels were randomized to Cutting Balloon dilation.
|
High Pressure Balloon (HPB)
Resistant Vessels with Pulmonary Artery Stenosis were identified during catheterization and vessels were randomized to High Pressure Balloon dilation.
|
|---|---|---|
|
Overall Study
STARTED
|
65 107
|
47 66
|
|
Overall Study
COMPLETED
|
65 106
|
47 65
|
|
Overall Study
NOT COMPLETED
|
0 1
|
0 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cutting Balloon Study
Baseline characteristics by cohort
| Measure |
Patients With Resistant Pulmonary Artery Stenosis
n=173 Vessels
Vessels with resistant PA stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation.
171 vessels in 73 patients were studied. Individual participants could have vessels randomized to one or both arms of the trial.
|
|---|---|
|
Age, Categorical
<=18 years
|
72 Participants
n=73 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=73 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=73 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=73 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=73 Participants
|
|
Greater than 1/2 systemic RV pressure
|
60 Participants
n=73 Participants
|
|
Regional decrease in pulmonary flow
|
58 Participants
n=73 Participants
|
|
Elevated PA pressure (mean >20)
|
47 Participants
n=73 Participants
|
|
Cyanosis in part due to PA stenosis
|
19 Participants
n=73 Participants
|
PRIMARY outcome
Timeframe: Pre-intervention to immediate post-intervention (approximately 10 minutes)Population: Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation. Patients had variable number of eligible vessels. Each eligible vessel was randomized at the time of procedure.
The primary efficacy outcome is the percent change in minimum lumen diameter from pre-intervention to immediately post-intervention as measured by angiography.
Outcome measures
| Measure |
Patients With Resistant Pulmonary Artery Stenosis
n=171 vessels
Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation.
|
|---|---|
|
Acute Change in Minimum Lumen Diameter Immediately Post-intervention
Cutting Balloon
|
85.1 percentage change
Standard Deviation 77.1
|
|
Acute Change in Minimum Lumen Diameter Immediately Post-intervention
High Pressure Balloon Dilation
|
52.4 percentage change
Standard Deviation 66
|
SECONDARY outcome
Timeframe: 3 months post-interventionPopulation: Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation.
Late percent change in minimum lumen diameter from pre-intervention to follow-up angiography.
Outcome measures
| Measure |
Patients With Resistant Pulmonary Artery Stenosis
n=76 vessels
Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation.
|
|---|---|
|
Percent Change in Minimum Lumen Diameter at 3 Months Post-intervention
Cutting Balloon
|
75.6 percent change
Standard Deviation 97.8
|
|
Percent Change in Minimum Lumen Diameter at 3 Months Post-intervention
High Pressure Balloon Dilation
|
42.2 percent change
Standard Deviation 66.9
|
Adverse Events
Patients With Resistant Pulmonary Artery Stenosis
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients With Resistant Pulmonary Artery Stenosis
n=73 participants at risk
Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon (CB) or High Pressure Balloon Dilation (HPB). Of the 73 patients, 26 received CB dilation only, 8 patients received HPB dilation only, and 39 patients received both CB and HPB dilations. Therefore, 65/73 patients were exposed to CB and 47/73 patients were exposed to HPB. Due to the overlap in treatment amongst patients, adverse events are reported on the patient level and not by intervention type.
|
|---|---|
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Cardiac disorders
Device malfunction
|
2.7%
2/73 • Number of events 2 • Patients were monitored for adverse events from the time of enrollment to follow-up assessment 2-4 months after the intervention.
|
|
Cardiac disorders
Balloon Rupture
|
4.1%
3/73 • Number of events 3 • Patients were monitored for adverse events from the time of enrollment to follow-up assessment 2-4 months after the intervention.
|
|
Cardiac disorders
Balloon caught on stent
|
1.4%
1/73 • Number of events 1 • Patients were monitored for adverse events from the time of enrollment to follow-up assessment 2-4 months after the intervention.
|
|
Cardiac disorders
Fracture of catheter shaft
|
1.4%
1/73 • Number of events 1 • Patients were monitored for adverse events from the time of enrollment to follow-up assessment 2-4 months after the intervention.
|
|
Cardiac disorders
Pulmonary Edema
|
13.7%
10/73 • Number of events 10 • Patients were monitored for adverse events from the time of enrollment to follow-up assessment 2-4 months after the intervention.
|
|
Cardiac disorders
Intravascular tear
|
1.4%
1/73 • Number of events 1 • Patients were monitored for adverse events from the time of enrollment to follow-up assessment 2-4 months after the intervention.
|
|
Cardiac disorders
Hemoptysis, hypotension
|
1.4%
1/73 • Number of events 1 • Patients were monitored for adverse events from the time of enrollment to follow-up assessment 2-4 months after the intervention.
|
|
Cardiac disorders
Heart Block
|
1.4%
1/73 • Number of events 1 • Patients were monitored for adverse events from the time of enrollment to follow-up assessment 2-4 months after the intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place