Trial Outcomes & Findings for IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA) (NCT NCT01566461)
NCT ID: NCT01566461
Last Updated: 2019-02-12
Results Overview
Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
331 participants
Primary outcome timeframe
12 month
Results posted on
2019-02-12
Participant Flow
The IN.PACT SFA Trial was designed as a two-phase randomized trial. IN.PACT SFA I, the first phase, was conducted in Europe with 150 subjects enrolled. IN.PACT SFA II, the second phase, was conducted in the US with 181 subjects enrolled. The randomized data from both phases are pooled and comprise the pivotal trial data.
Participant milestones
| Measure |
Drug-Coated Balloon (DCB)
Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm
|
Standard PTA
Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
IN.PACT SFA I Phase
STARTED
|
99
|
51
|
|
IN.PACT SFA I Phase
COMPLETED
|
88
|
49
|
|
IN.PACT SFA I Phase
NOT COMPLETED
|
11
|
2
|
|
IN.PACT SFA II Phase
STARTED
|
121
|
60
|
|
IN.PACT SFA II Phase
COMPLETED
|
109
|
55
|
|
IN.PACT SFA II Phase
NOT COMPLETED
|
12
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
Baseline characteristics by cohort
| Measure |
Drug-Coated Balloon (DCB)
n=220 Participants
Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=111 Participants
Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
68.0 Years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
67.6 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=191 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=103 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Primary Patency
|
82.2 Percentage of participants
|
52.4 Percentage of participants
|
PRIMARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=207 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=107 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Primary Safety Composite
|
95.7 Percentage of particpants
|
76.6 Percentage of particpants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=207 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=107 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Major Adverse Event (MAE) Composite
|
6.3 Percentage of participants
|
24.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=207 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=107 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
All-cause Death
|
1.9 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=207 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=107 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Target Vessel Revascularization (TVR)
|
4.8 Percentage of participants
|
23.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=207 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=107 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Target Lesion Revascularization (TLR)
|
2.9 Percentage of participants
|
20.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Includes all subjects who experienced a CD-TLR.
Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \>0.15 when compared to post procedure baseline.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=5 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=22 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)
|
144.6 Days
Standard Deviation 159.6
|
201.9 Days
Standard Deviation 90.9
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=207 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=107 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Major Target Limb Amputation
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=207 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=107 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Thrombosis at the Target Lesion
|
1.4 Percentage of participants
|
3.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=196 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=106 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Primary Sustained Clinical Improvement
|
85.2 Percentage of participants
|
68.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Freedom from target amputation and increase in Rutherford class.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=196 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=104 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Secondary Sustained Clinical Improvement
|
89.3 Percentage of particpants
|
84.6 Percentage of particpants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=188 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=86 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)
|
16.5 Percentage of participants
|
33.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=178 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=84 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)
|
7.3 Percentage of participants
|
21.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used. EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=193 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=102 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)
|
0.1059 Units on a scale
Standard Deviation 0.2089
|
0.0730 Units on a scale
Standard Deviation 0.1951
|
SECONDARY outcome
Timeframe: From baseline to 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe. Data not collected in IN.PACT SFA I phase.
Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=91 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=45 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)
|
38.7 Meters
Standard Deviation 92.1
|
59.1 Meters
Standard Deviation 102.3
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication. Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment).
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=196 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=104 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)
|
72.7 Units on a scale
Standard Deviation 31.4
|
73.6 Units on a scale
Standard Deviation 29.5
|
SECONDARY outcome
Timeframe: Day 1Population: Total number of devices used in the ITT population (n=331).
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=311 Devices
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=130 Devices
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Device Success
|
99.0 Percentage of devices
|
98.5 Percentage of devices
|
SECONDARY outcome
Timeframe: Day 1Population: Intention-to-Treat (n=331)
Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=220 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=111 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Procedural Success
|
99.5 Percentage of participants
|
98.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intention-to-Treat (n=331)
Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=220 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=111 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Clinical Success
|
99.1 Percentage of participants
|
97.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.
Days of hospitalization from procedure through 12 month.
Outcome measures
| Measure |
Drug-Coated Balloon (DCB)
n=219 Participants
IN.PACT Admiral: Balloon Angioplasty
IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=111 Participants
Standard PTA Balloon: Balloon Angioplasty
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Days of Hospitalization Due to the Index Lesion
|
1.3 Days
Standard Deviation 1.9
|
1.7 Days
Standard Deviation 2.0
|
Adverse Events
Drug-Coated Balloon (DCB)
Serious events: 102 serious events
Other events: 104 other events
Deaths: 0 deaths
Standard PTA
Serious events: 62 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug-Coated Balloon (DCB)
n=220 participants at risk
Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=111 participants at risk
Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.4%
3/220 • Number of events 3
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
General disorders
Adverse Drug Reaction
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Amnesia
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
4/220 • Number of events 4
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
MedDRA 13.0
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Cardiac disorders
Angina Pectoris
|
0.91%
2/220 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Vascular disorders
Aorto-Duodenal Fistula
|
0.00%
0/220
|
0.00%
0/111
|
|
Cardiac disorders
Arrhythmia
|
0.45%
1/220 • Number of events 2
|
0.00%
0/111
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Arterial Restenosis
|
0.45%
1/220 • Number of events 1
|
3.6%
4/111 • Number of events 4
|
|
Vascular disorders
Arterial Stenosis Limb
|
0.45%
1/220 • Number of events 1
|
2.7%
3/111 • Number of events 3
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.00%
0/220
|
0.00%
0/111
|
|
Vascular disorders
Arteriovenous Fistula
|
0.00%
0/220
|
1.8%
2/111 • Number of events 2
|
|
Vascular disorders
Artery Dissection
|
3.2%
7/220 • Number of events 8
|
1.8%
2/111 • Number of events 2
|
|
Infections and infestations
Arthritis Bacterial
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Cardiac disorders
Atrial Fibrillation
|
0.91%
2/220 • Number of events 2
|
1.8%
2/111 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.45%
1/220 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Infections and infestations
Biliary Sepsis
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Cardiac disorders
Cardiac Arrest
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.7%
6/220 • Number of events 6
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Carotid Artery Disease
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.45%
1/220 • Number of events 1
|
1.8%
2/111 • Number of events 2
|
|
Infections and infestations
Cellulitis
|
0.00%
0/220
|
0.00%
0/111
|
|
Nervous system disorders
Cerebral Infarction
|
0.45%
1/220 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
General disorders
Chest Pain
|
0.91%
2/220 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Cardiac disorders
Coronary Artery Disease
|
3.2%
7/220 • Number of events 7
|
0.90%
1/111 • Number of events 1
|
|
Cardiac disorders
Coronary Artery Thrombosis
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Device Occlusion
|
0.45%
1/220 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/220
|
0.00%
0/111
|
|
Metabolism and nutrition disorders
Diabetic Foot
|
0.00%
0/220
|
0.00%
0/111
|
|
Eye disorders
Diabetic Retinopathy
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Skin and subcutaneous tissue disorders
Dry Gangrene
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Embolic Cerebral Infarction
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Vascular disorders
Femoral Arterial Stenosis
|
6.8%
15/220 • Number of events 18
|
9.0%
10/111 • Number of events 12
|
|
Vascular disorders
Femoral Artery Dissection
|
1.8%
4/220 • Number of events 4
|
4.5%
5/111 • Number of events 5
|
|
Vascular disorders
Femoral Artery Occlusion
|
1.4%
3/220 • Number of events 5
|
4.5%
5/111 • Number of events 5
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.45%
1/220 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Fractured Coccyx
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Infections and infestations
Gangrene
|
0.91%
2/220 • Number of events 2
|
0.00%
0/111
|
|
Infections and infestations
Gastroenteritis
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.91%
2/220 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Vascular disorders
Haematoma
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Vascular disorders
Haemorrhage
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Hypoaesthesia
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Vascular disorders
Hypotension
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Vascular disorders
Iliac Artery Occlusion
|
0.00%
0/220
|
0.00%
0/111
|
|
Vascular disorders
Iliac Artery Stenosis
|
0.91%
2/220 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
General disorders
Impaired Healing
|
0.45%
1/220 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Implant Site Thrombosis
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
In-Stent Arterial Restenosis
|
1.4%
3/220 • Number of events 3
|
0.90%
1/111 • Number of events 1
|
|
Injury, poisoning and procedural complications
In-Stent Coronary Artery Restenosis
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Infections and infestations
Infected Lymphocele
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Vascular disorders
Intermittent Claudication
|
3.2%
7/220 • Number of events 7
|
9.9%
11/111 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Surgical and medical procedures
Joint Surgery
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Hepatobiliary disorders
Liver Disorder
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Infections and infestations
Localised Infection
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.91%
2/220 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/220
|
0.00%
0/111
|
|
General disorders
Mass
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/220
|
0.00%
0/111
|
|
General disorders
Multi-Organ Failure
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Cardiac disorders
Myocardial Infarction
|
0.91%
2/220 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
General disorders
Necrosis
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Neuropathic Ulcer
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Metabolism and nutrition disorders
Obesity
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
General disorders
Oedema Peripheral
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Vascular disorders
Orthostatic Hypotension
|
0.45%
1/220 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.91%
2/220 • Number of events 2
|
0.00%
0/111
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/220
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.91%
2/220 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.45%
1/220 • Number of events 2
|
0.00%
0/111
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.00%
0/220
|
0.00%
0/111
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
3.6%
8/220 • Number of events 8
|
4.5%
5/111 • Number of events 5
|
|
Injury, poisoning and procedural complications
Peripheral Arterial Reocclusion
|
0.00%
0/220
|
3.6%
4/111 • Number of events 4
|
|
Vascular disorders
Peripheral Artery Dissection
|
1.4%
3/220 • Number of events 3
|
3.6%
4/111 • Number of events 5
|
|
Vascular disorders
Peripheral Embolism
|
0.45%
1/220 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Vascular disorders
Peripheral Ischaemia
|
0.91%
2/220 • Number of events 4
|
1.8%
2/111 • Number of events 2
|
|
Surgical and medical procedures
Peripheral Revascularisation
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.91%
2/220 • Number of events 2
|
0.00%
0/111
|
|
Gastrointestinal disorders
Peritonitis
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Infections and infestations
Pneumonia
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
General disorders
Polyp
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Investigations
Prostatic Specific Antigen Increased
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.45%
1/220 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Vascular disorders
Shock Haemorrhagic
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Cardiac disorders
Sinus Tachycardia
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Vascular disorders
Subclavian Artery Stenosis
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Sudden Death
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/220
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.45%
1/220 • Number of events 1
|
1.8%
2/111 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Surgical and medical procedures
Therapeutic Embolisation
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil Cancer
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.4%
3/220 • Number of events 3
|
0.00%
0/111
|
|
Infections and infestations
Urinary Tract Infection
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
0.45%
1/220 • Number of events 2
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
1.4%
3/220 • Number of events 3
|
2.7%
3/111 • Number of events 3
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
Ear and labyrinth disorders
Vertigo
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.91%
2/220 • Number of events 2
|
0.00%
0/111
|
|
Infections and infestations
West Nile Viral Infection
|
0.45%
1/220 • Number of events 1
|
0.00%
0/111
|
Other adverse events
| Measure |
Drug-Coated Balloon (DCB)
n=220 participants at risk
Paclitaxel drug-coated angioplasty balloon
IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm
|
Standard PTA
n=111 participants at risk
Standard angioplasty balloon without Paclitaxel drug-coating
Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm
|
|---|---|---|
|
Vascular disorders
Artery Dissection
|
20.9%
46/220 • Number of events 46
|
32.4%
36/111 • Number of events 37
|
|
Vascular disorders
Femoral Artery Dissection
|
13.2%
29/220 • Number of events 29
|
9.9%
11/111 • Number of events 11
|
|
Vascular disorders
Intermittent Claudication
|
5.5%
12/220 • Number of events 12
|
13.5%
15/111 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
9.5%
21/220 • Number of events 22
|
7.2%
8/111 • Number of events 8
|
|
Vascular disorders
Peripheral Artery Dissection
|
6.4%
14/220 • Number of events 14
|
8.1%
9/111 • Number of events 11
|
|
General disorders
Vessel Puncture Site Haematoma
|
5.9%
13/220 • Number of events 13
|
0.00%
0/111
|
Additional Information
Arslan Malik, Sr. Clinical Research Manager
Medtronic Endovascular Therapies
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60