Trial Outcomes & Findings for Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV) (NCT NCT04058990)
NCT ID: NCT04058990
Last Updated: 2026-05-11
Results Overview
TLF is defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
6 months post procedure
Results posted on
2026-05-11
Participant Flow
Participant milestones
| Measure |
Agent Paclitaxel-Coated PTCA Balloon Catheter - Randomized
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
Device: Paclitaxel-Coated PTCA Balloon Catheter: Percutaneous Transluminal Coronary Angioplasty
|
SeQuent Please Drug Eluting Balloon Catheter - Randomized
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (SeQuent Please Drug Eluting Balloon Catheter with paclitaxel 3.0 μg/mm²)
SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel: Percutaneous Transluminal Coronary Angioplasty
|
Agent DCB - Single Arm ISR Sub Study
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
Device: Paclitaxel-Coated PTCA Balloon Catheter: Percutaneous Transluminal Coronary Angioplasty
|
|---|---|---|---|
|
Overall Study
STARTED
|
101
|
49
|
30
|
|
Overall Study
COMPLETED
|
100
|
49
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
Baseline characteristics by cohort
| Measure |
Agent Paclitaxel-Coated PTCA Balloon Catheter - Randomized
n=101 Participants
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
Device: Paclitaxel-Coated PTCA Balloon Catheter: Percutaneous Transluminal Coronary Angioplasty
|
SeQuent Please Drug Eluting Balloon Catheter - Randomized
n=49 Participants
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (SeQuent Please Drug Eluting Balloon Catheter with paclitaxel 3.0 μg/mm²)
SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel: Percutaneous Transluminal Coronary Angioplasty
|
Agent DCB - Single Arm ISR Sub Study
n=30 Participants
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
Device: Paclitaxel-Coated PTCA Balloon Catheter: Percutaneous Transluminal Coronary Angioplasty
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Agent Paclitaxel-Coated PTCA Balloon Catheter - Randomized
|
68.37 years
STANDARD_DEVIATION 10.62 • n=44 Participants
|
0 years
STANDARD_DEVIATION 0 • n=10 Participants
|
0 years
STANDARD_DEVIATION 0 • n=30 Participants
|
68.37 years
STANDARD_DEVIATION 10.62 • n=1054 Participants
|
|
Age, Continuous
SeQuent Please Drug Eluting Balloon Catheter - Randomized
|
0 years
STANDARD_DEVIATION 0 • n=44 Participants
|
67.73 years
STANDARD_DEVIATION 10.38 • n=10 Participants
|
0 years
STANDARD_DEVIATION 0 • n=30 Participants
|
67.73 years
STANDARD_DEVIATION 10.38 • n=1054 Participants
|
|
Age, Continuous
Agent DCB - Single Arm ISR Sub Study
|
0 years
STANDARD_DEVIATION 0 • n=44 Participants
|
0 years
STANDARD_DEVIATION 0 • n=10 Participants
|
68.50 years
STANDARD_DEVIATION 11.71 • n=30 Participants
|
68.50 years
STANDARD_DEVIATION 11.71 • n=1054 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=44 Participants
|
38 Participants
n=10 Participants
|
26 Participants
n=30 Participants
|
139 Participants
n=1054 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=44 Participants
|
11 Participants
n=10 Participants
|
4 Participants
n=30 Participants
|
41 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
101 Participants
n=44 Participants
|
49 Participants
n=10 Participants
|
30 Participants
n=30 Participants
|
180 Participants
n=1054 Participants
|
|
Region of Enrollment
Japan
|
101 Participants
n=44 Participants
|
49 Participants
n=10 Participants
|
30 Participants
n=30 Participants
|
180 Participants
n=1054 Participants
|
|
Stable Angina
|
98 Participants
n=44 Participants
|
45 Participants
n=10 Participants
|
29 Participants
n=30 Participants
|
172 Participants
n=1054 Participants
|
|
Unstable Angina
|
3 Participants
n=44 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
8 Participants
n=1054 Participants
|
PRIMARY outcome
Timeframe: 6 months post procedurePopulation: Non-inferiority analysis - ITT population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device.
TLF is defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Outcome measures
| Measure |
Agent Paclitaxel-Coated PTCA Balloon Catheter
n=101 Participants
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
Device: Paclitaxel-Coated PTCA Balloon Catheter: Percutaneous Transluminal Coronary Angioplasty
|
SeQuent Please Drug Eluting Balloon Catheter
n=49 Participants
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (SeQuent Please Drug Eluting Balloon Catheter with paclitaxel 3.0 μg/mm²)
SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel: Percutaneous Transluminal Coronary Angioplasty
|
|---|---|---|
|
Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)
|
3 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post procedureTLF is defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Outcome measures
| Measure |
Agent Paclitaxel-Coated PTCA Balloon Catheter
n=30 Participants
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
Device: Paclitaxel-Coated PTCA Balloon Catheter: Percutaneous Transluminal Coronary Angioplasty
|
SeQuent Please Drug Eluting Balloon Catheter
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (SeQuent Please Drug Eluting Balloon Catheter with paclitaxel 3.0 μg/mm²)
SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel: Percutaneous Transluminal Coronary Angioplasty
|
|---|---|---|
|
Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)
|
1 Participants
|
—
|
Adverse Events
Agent Paclitaxel-Coated PTCA Balloon Catheter
Serious events: 15 serious events
Other events: 46 other events
Deaths: 0 deaths
SeQuent Please Drug Eluting Balloon Catheter
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Agent DCB - Single Arm ISR Sub Study
Serious events: 3 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Agent Paclitaxel-Coated PTCA Balloon Catheter
n=101 participants at risk
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
Device: Paclitaxel-Coated PTCA Balloon Catheter: Percutaneous Transluminal Coronary Angioplasty
|
SeQuent Please Drug Eluting Balloon Catheter
n=49 participants at risk
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (SeQuent Please Drug Eluting Balloon Catheter with paclitaxel 3.0 μg/mm²)
SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel: Percutaneous Transluminal Coronary Angioplasty
|
Agent DCB - Single Arm ISR Sub Study
n=30 participants at risk
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
Device: Paclitaxel-Coated PTCA Balloon Catheter: Percutaneous Transluminal Coronary Angioplasty
|
|---|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
6.9%
7/101 • Number of events 9 • 6 months following procedure
|
6.1%
3/49 • Number of events 3 • 6 months following procedure
|
6.7%
2/30 • Number of events 2 • 6 months following procedure
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
2.0%
2/101 • Number of events 2 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
3.3%
1/30 • Number of events 1 • 6 months following procedure
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
2.0%
2/101 • Number of events 2 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
2.0%
2/101 • Number of events 2 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Eye disorders
Eye disorders
|
0.99%
1/101 • Number of events 1 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Infections and infestations
Infections and infestations
|
0.99%
1/101 • Number of events 1 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
0.99%
1/101 • Number of events 1 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Nervous system disorders
Nervous system disorders
|
0.99%
1/101 • Number of events 1 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.99%
1/101 • Number of events 1 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Vascular disorders
Vascular disorders
|
0.00%
0/101 • 6 months following procedure
|
2.0%
1/49 • Number of events 1 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
Other adverse events
| Measure |
Agent Paclitaxel-Coated PTCA Balloon Catheter
n=101 participants at risk
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
Device: Paclitaxel-Coated PTCA Balloon Catheter: Percutaneous Transluminal Coronary Angioplasty
|
SeQuent Please Drug Eluting Balloon Catheter
n=49 participants at risk
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (SeQuent Please Drug Eluting Balloon Catheter with paclitaxel 3.0 μg/mm²)
SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel: Percutaneous Transluminal Coronary Angioplasty
|
Agent DCB - Single Arm ISR Sub Study
n=30 participants at risk
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
Device: Paclitaxel-Coated PTCA Balloon Catheter: Percutaneous Transluminal Coronary Angioplasty
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps
|
0.99%
1/101 • Number of events 1 • 6 months following procedure
|
2.0%
1/49 • Number of events 1 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Psychiatric disorders
Psychiatric disorders
|
0.99%
1/101 • Number of events 1 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
3.3%
1/30 • Number of events 1 • 6 months following procedure
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.99%
1/101 • Number of events 1 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Immune system disorders
Immune system disorders
|
0.00%
0/101 • 6 months following procedure
|
2.0%
1/49 • Number of events 1 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Gastrointestinal disorders
General disorders and administration site conditions
|
7.9%
8/101 • Number of events 10 • 6 months following procedure
|
6.1%
3/49 • Number of events 4 • 6 months following procedure
|
10.0%
3/30 • Number of events 3 • 6 months following procedure
|
|
General disorders
Gastrointestinal disorders
|
5.9%
6/101 • Number of events 8 • 6 months following procedure
|
6.1%
3/49 • Number of events 3 • 6 months following procedure
|
3.3%
1/30 • Number of events 2 • 6 months following procedure
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
6.9%
7/101 • Number of events 7 • 6 months following procedure
|
8.2%
4/49 • Number of events 4 • 6 months following procedure
|
6.7%
2/30 • Number of events 2 • 6 months following procedure
|
|
Infections and infestations
Infections and infestations
|
6.9%
7/101 • Number of events 7 • 6 months following procedure
|
4.1%
2/49 • Number of events 2 • 6 months following procedure
|
6.7%
2/30 • Number of events 2 • 6 months following procedure
|
|
Eye disorders
Eye disorders
|
3.0%
3/101 • Number of events 4 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
3.3%
1/30 • Number of events 1 • 6 months following procedure
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
4.0%
4/101 • Number of events 4 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
6.7%
2/30 • Number of events 2 • 6 months following procedure
|
|
Vascular disorders
Vascular disorders
|
3.0%
3/101 • Number of events 3 • 6 months following procedure
|
8.2%
4/49 • Number of events 5 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
3.0%
3/101 • Number of events 3 • 6 months following procedure
|
4.1%
2/49 • Number of events 2 • 6 months following procedure
|
10.0%
3/30 • Number of events 4 • 6 months following procedure
|
|
Nervous system disorders
Nervous system disorders
|
3.0%
3/101 • Number of events 3 • 6 months following procedure
|
4.1%
2/49 • Number of events 2 • 6 months following procedure
|
3.3%
1/30 • Number of events 1 • 6 months following procedure
|
|
Investigations
Investigations
|
2.0%
2/101 • Number of events 3 • 6 months following procedure
|
2.0%
1/49 • Number of events 1 • 6 months following procedure
|
10.0%
3/30 • Number of events 4 • 6 months following procedure
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.0%
2/101 • Number of events 2 • 6 months following procedure
|
2.0%
1/49 • Number of events 1 • 6 months following procedure
|
3.3%
1/30 • Number of events 1 • 6 months following procedure
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
2.0%
2/101 • Number of events 2 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
2.0%
2/101 • Number of events 2 • 6 months following procedure
|
0.00%
0/49 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
|
Cardiac disorders
Cardiac disorders
|
9.9%
10/101 • Number of events 13 • 6 months following procedure
|
10.2%
5/49 • Number of events 5 • 6 months following procedure
|
10.0%
3/30 • Number of events 3 • 6 months following procedure
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
12.9%
13/101 • Number of events 13 • 6 months following procedure
|
4.1%
2/49 • Number of events 2 • 6 months following procedure
|
0.00%
0/30 • 6 months following procedure
|
Additional Information
Sachiyo Sato/Clinical Project Manager
Boston Scientific Japan K.K.
Phone: +81-3-6853-7500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The restriction depends on the conditions on the Clinical Study Agreement at each site. The PI must notify the sponsor about the publication and receive the approval from the sponsor prior to any results/data relavant to the AGENT Japan trial to be in public.
- Publication restrictions are in place
Restriction type: OTHER