Trial Outcomes & Findings for Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - Drug Coated Balloon (NCT NCT02812966)
NCT ID: NCT02812966
Last Updated: 2024-10-08
Results Overview
Peak systolic velocity ratio \<=2.4 (by duplex ultrasound scanning) with no target lesion revascularization or target lesion bypass
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
12 months
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
Lutonix Drug Coated Balloon
Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter
Lutonix: Drug Coated Balloons
|
IN.PACT Drug Coated Balloon
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
IN.PACT: Drug Coated Balloons
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lutonix Drug Coated Balloon
Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter
Lutonix: Drug Coated Balloons
|
IN.PACT Drug Coated Balloon
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
IN.PACT: Drug Coated Balloons
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
No data received on 4 subjects in the Lutonix Drug Coated Balloon arm. No data received on 4 subjects in the IN.PACT Drug Coated Balloon arm.
Baseline characteristics by cohort
| Measure |
Lutonix Drug Coated Balloon
n=18 Participants
Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter
Lutonix: Drug Coated Balloons
|
IN.PACT Drug Coated Balloon
n=17 Participants
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
IN.PACT: Drug Coated Balloons
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=18 Participants
|
8 Participants
n=17 Participants
|
17 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=18 Participants
|
9 Participants
n=17 Participants
|
18 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=14 Participants • No data received on 4 subjects in the Lutonix Drug Coated Balloon arm. No data received on 4 subjects in the IN.PACT Drug Coated Balloon arm.
|
8 Participants
n=13 Participants • No data received on 4 subjects in the Lutonix Drug Coated Balloon arm. No data received on 4 subjects in the IN.PACT Drug Coated Balloon arm.
|
18 Participants
n=27 Participants • No data received on 4 subjects in the Lutonix Drug Coated Balloon arm. No data received on 4 subjects in the IN.PACT Drug Coated Balloon arm.
|
|
Sex: Female, Male
Male
|
4 Participants
n=14 Participants • No data received on 4 subjects in the Lutonix Drug Coated Balloon arm. No data received on 4 subjects in the IN.PACT Drug Coated Balloon arm.
|
5 Participants
n=13 Participants • No data received on 4 subjects in the Lutonix Drug Coated Balloon arm. No data received on 4 subjects in the IN.PACT Drug Coated Balloon arm.
|
9 Participants
n=27 Participants • No data received on 4 subjects in the Lutonix Drug Coated Balloon arm. No data received on 4 subjects in the IN.PACT Drug Coated Balloon arm.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=18 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=18 Participants
|
12 Participants
n=17 Participants
|
24 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=18 Participants
|
4 Participants
n=17 Participants
|
9 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=18 Participants
|
9 Participants
n=17 Participants
|
14 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=18 Participants
|
4 Participants
n=17 Participants
|
12 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=18 Participants
|
4 Participants
n=17 Participants
|
9 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
17 participants
n=17 Participants
|
35 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data were not collected. Insufficient number of participants enrolled to perform data analysis prior to study closure. No data displayed because outcome measure had zero total participants analyzed.
Peak systolic velocity ratio \<=2.4 (by duplex ultrasound scanning) with no target lesion revascularization or target lesion bypass
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data were not collected. Insufficient number of participants enrolled to perform data analysis prior to study closure.
To examine, describe and compare/contrast within and between Drug Coated Balloon groups. 1. Target lesion revascularization rate 2. Safety event rate 3. Healthcare utilization costs
Outcome measures
Outcome data not reported
Adverse Events
Lutonix Drug Coated Balloon
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
IN.PACT Drug Coated Balloon
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lutonix Drug Coated Balloon
n=18 participants at risk
Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter
Lutonix: Drug Coated Balloons
|
IN.PACT Drug Coated Balloon
n=17 participants at risk
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
IN.PACT: Drug Coated Balloons
|
|---|---|---|
|
Nervous system disorders
subdural hematoma
|
5.6%
1/18 • Number of events 1 • In this study we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of enrollment/randomization through study exit, up to 12 months.
Participants asked when they came in if there was an adverse event
|
0.00%
0/17 • In this study we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of enrollment/randomization through study exit, up to 12 months.
Participants asked when they came in if there was an adverse event
|
Other adverse events
Adverse event data not reported
Additional Information
Director, Clinical Trials Research Cardiovascular and Multiple Specialties
Advocate Aurora Research Institute
Phone: 708-860-7792
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place