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Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
NA trial testing Device: Paclitaxel-Coated PTCA Balloon Catheter in Coronary Artery Disease in 180 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 12 December 2019 |
| Primary completion | 22 December 2021 |
| Estimated completion | 30 June 2026 |
| Sites | 14 locations across Japan |
Boston Scientific Corporation — full company profile →
20 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Agent Paclitaxel-Coated PTCA Balloon Catheter | 3 | |
| SeQuent Please Drug Eluting Balloon Catheter | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Agent DCB - Single Arm ISR Sub Study | 1 |
Time frame: 6 months following procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Agent Paclitaxel-Coated PT… | SeQuent Please Drug Elutin… | Agent DCB - Single Arm ISR… |
|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | — | — | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — | — | — |
| Hepatobiliary disorders | Hepatobiliary disorders | — | — | — |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | — | — | — |
| Eye disorders | Eye disorders | — | — | — |
| Infections and infestations | Infections and infestations | — | — | — |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Nervous system disorders | Nervous system disorders | — | — | — |
| Renal and urinary disorders | Renal and urinary disorders | — | — | — |
| Vascular disorders | Vascular disorders | — | — | — |
| Reaction | System | Agent Paclitaxel-Coated PT… | SeQuent Please Drug Elutin… | Agent DCB - Single Arm ISR… |
|---|---|---|---|---|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | — | — | — |
| Cardiac disorders | Cardiac disorders | — | — | — |
| General disorders and administration site conditions | Gastrointestinal disorders | — | — | — |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | — | — | — |
| Infections and infestations | Infections and infestations | — | — | — |
| Gastrointestinal disorders | General disorders | — | — | — |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | — | — | — |
| Vascular disorders | Vascular disorders | — | — | — |
| Eye disorders | Eye disorders | — | — | — |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | — | — | — |
| Nervous system disorders | Nervous system disorders | — | — | — |
| Investigations | Investigations | — | — | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Ear and labyrinth disorders | Ear and labyrinth disorders | — | — | — |
| Hepatobiliary disorders | Hepatobiliary disorders | — | — | — |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Psychiatric disorders | Psychiatric disorders | — | — | — |
| Renal and urinary disorders | Renal and urinary disorders | — | — | — |
| Immune system disorders | Immune system disorders | — | — | — |
Most-reported serious reactions: Cardiac disorders, Gastrointestinal disorders, Hepatobiliary disorders, Injury, poisoning and procedural complications, Eye disorders, Infections and infestations, Neoplasms benign, malignant and unspecified (incl cysts and polyps), Nervous system disorders.
Data from ClinicalTrials.gov NCT04058990 adverse events section.
A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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