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Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)

Primary Purpose

Coronary Artery Disease

Status
Active
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Device: Paclitaxel-Coated PTCA Balloon Catheter
SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject must be at least 20 years of age.
  2. Subject understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
  3. Subject is eligible for percutaneous coronary intervention (PCI).
  4. Subject has documented stable angina pectoris or unstable angina pectoris. If subject has documented stable angina pectoris, one of the following criteria meet.

    • ≥90% diameter stenosis.
    • Stenosis that is considered a cause of stable effort angina (Only when it's without confirmation of significant stenosis).
    • Stenosis that is confirmed a cause of functional ischemia with any test.
  5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG).
  6. Subject is willing to comply with all protocol-required follow-up evaluation.
  7. Patients undergoing first or second treatment for ISR lesions for the non-randomized ISR substudy.
  8. The target lesion meets all following criteria.

    • Target lesion length must measure (by visual estimate) ≤28 mm.
    • Target lesion must be a visually estimated reference vessel diameter (RVD) ≥2.00mm and <3.00 mm (This applys for SV trial. For ISR substudy: RVD ≥2.00mm and ≤4.00 mm.).
    • Target lesion must be a de novo lesion located in a native coronary artery with visually estimated stenosis ≥75% and <100% (This applys for SV trial. For ISR substudy: Target lesion for ISR must be in-stent restenosis of a previously-treated lesion located in a native coronary artery with visually estimated stenosis ≥75% and <100%.).
    • Coronary anatomy is likely to allow delivery of an investigational device to the lesions.
    • Target lesion must be successfully pre-dilated.
  9. Planned treatment of 2 coronary artery lesions in 2 vessels may be treated (For SV trial, up to two lesions per vessel can be treated. For ISR substudy, single lesion per vessel can be treated.).

Exclusion Criteria:

  1. Subject has had an acute myocardial infarction within 72 hours prior to the index procedure.
  2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina.
  3. Subject has severe left ventricular dysfunction with ejection fraction <30%.
  4. Subject has received an organ transplant or is on a waiting list for an organ transplant.
  5. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure.
  6. Subject has renal failure with a serum creatinine of > 2.0mg/dL or who is receiving dialysis or chronic immunosuppressant therapy.
  7. Subjects has one of the following.

    • Not expected to live for the duration of the study (1 year) by investigator's discretion due to other serious medical illness.
    • Current problems with substance abuse.
    • Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
  8. Planned PCI (including staged procedures) or CABG after the index procedure.
  9. Subject previously treated at any time with intravascular brachytherapy.
  10. Subject has a known allergy to contrast and/or the investigational device or protocol-required concomitant medications, iopromide, raw materials of Agent DCB and SeQuent Please DCB, P2Y12 inhibitor or aspirin).
  11. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
  12. Subject has a white blood cell (WBC) count < 3,000 cells/mm3.
  13. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis.
  14. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  15. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
  16. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
  17. Target vessel has been treated with Paclitaxel Eluting Stent or Balloon prior to the index procedure.
  18. Target vessel has been treated with any type of PCI within 6 months prior to the index procedure.
  19. Target vessel requires the use of adjunctive primary treatment modalities immediately prior to investigational device's treatment.
  20. Non-target vessel has been treated with any type of PCI within 24 hours prior to the index procedure.
  21. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint.
  22. Subject intends to participate in another investigational drug or device clinical trial within 6 months after the index procedure.
  23. Subject with known intention to procreate within 6 months after the index procedure.
  24. Subject is a woman who is pregnant or nursing.
  25. Target lesion meets any of the following criteria:

    • Left main location.
    • Located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate.
    • > 50% stenosis of an additional lesion proximal or distal to the target lesion (by visual estimate).
    • Located within a saphenous vein graft or an arterial graft.
    • Will be accessed via a saphenous vein graft or an arterial graft.
    • Involves a complex bifurcation (e.g., bifurcations requiring treatment with more than 1 stent).
    • TIMI flow 0 (total occlusion) prior to wire crossing.
    • Excessive tortuosity proximal to or within the lesion.
    • Extreme angulation proximal to or within the lesion.
    • Target lesion and/or target vessel proximal to the lesion is severely calcified by visual estimate to expect sub-optimal balloon expansion.
    • Target lesion and/or target vessel adjacent to the target lesion presents with dissection or aneurysm by visual estimate.
    • Restenosis from previous intervention (This is applicable only to SV trial.).
    • PCI within 10 mm proximal or distal to the target lesion (by visual estimate) at any time prior to the index procedure (This is applicable only to SV trial.).
    • Planned treatment of a single lesion with more than 1 investigational device.
    • In-stent restenosis due to stent fracture or recoil (This is applicable only to ISR substudy.).
  26. Non-target lesion to be treated during the index procedure meets any of the following criteria:

    • Located in the target vessel (This is applicable only to ISR substudy.).
    • Located within a bypass graft (venous or arterial).
    • Left main location.
    • Chronic total occlusion.
    • Involves a complex bifurcation.
    • Located within 15 mm of the proximal or distal shoulder of the target lesion by visual estimate in the case of the same vessel with a target lesion for SV trial.
  27. Subject has unprotected left main coronary artery disease (>50% diameter stenosis).
  28. Thrombus, or possible thrombus, present in the target vessel.
  29. Subject with known coronary artery spasm.

Sites / Locations

  • Kokura Memorial Hospital
  • Sapporo Higashi Tokushukai Hospital
  • Japan Labour Health and Welfare Organization Kanto Rosai Hospital
  • Shonan Kamakura General Hospital
  • Saiseikai Yokohama-City Eastern Hospital
  • Sendai Kousei Hospital
  • Osaka Saiseikai Nakatsu Hospital
  • Teikyo University Hospital
  • Toho University Ohashi Medical Center
  • Showa University Hospital
  • Tokyo Women's Medical University Hospital
  • Kyoto-Katsura Hospital
  • Miyazaki Medical Association Hospital
  • Sakurabashi Watanabe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Agent Paclitaxel-Coated PTCA Balloon Catheter

SeQuent Please Drug Eluting Balloon Catheter

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)
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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2019
Last Updated
December 2, 2022
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04058990
Brief Title
Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
Official Title
A 2:1 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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Primary objective is to evaluate the safety and effectiveness of the Agent ™ Paclitaxel-Coated PTCA Balloon Catheter for the treatment of Japanese subjects with a small vessel de novo native atherosclerotic coronary artery lesion or in-stent restenosis (ISR) of a previously treated lesion. Primary endpoint: Target Lesion Failure (TLF) rate at 6 months post index-procedure. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
SV study: A prospective, multicenter, 2:1 randomized, controlled, single-blind, non-inferiority trial.150 subjects are expected to be enrolled to support a 2:1 randomization. (Investigational test device: Agent DCB, N=100 subjects or Control device: SeQuent Please DCB, N=50 subjects) ISR substudy: A prospective, multicenter, single-arm, open-label trial. 30 subjects are expected to be enrolled.
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Agent Paclitaxel-Coated PTCA Balloon Catheter
Arm Type
Experimental
Arm Description
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)
Arm Title
SeQuent Please Drug Eluting Balloon Catheter
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Device: Paclitaxel-Coated PTCA Balloon Catheter
Intervention Description
Percutaneous Transluminal Coronary Angioplasty
Intervention Type
Device
Intervention Name(s)
SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel
Intervention Description
Percutaneous Transluminal Coronary Angioplasty
Primary Outcome Measure Information:
Title
Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)
Description
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.
Time Frame
6 months post procedure
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)
Description
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.
Time Frame
6 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must be at least 20 years of age. Subject understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. Subject is eligible for percutaneous coronary intervention (PCI). Subject has documented stable angina pectoris or unstable angina pectoris. If subject has documented stable angina pectoris, one of the following criteria meet. ≥90% diameter stenosis. Stenosis that is considered a cause of stable effort angina (Only when it's without confirmation of significant stenosis). Stenosis that is confirmed a cause of functional ischemia with any test. Subject is an acceptable candidate for coronary artery bypass grafting (CABG). Subject is willing to comply with all protocol-required follow-up evaluation. Patients undergoing first or second treatment for ISR lesions for the non-randomized ISR substudy. The target lesion meets all following criteria. Target lesion length must measure (by visual estimate) ≤28 mm. Target lesion must be a visually estimated reference vessel diameter (RVD) ≥2.00mm and <3.00 mm (This applys for SV trial. For ISR substudy: RVD ≥2.00mm and ≤4.00 mm.). Target lesion must be a de novo lesion located in a native coronary artery with visually estimated stenosis ≥75% and <100% (This applys for SV trial. For ISR substudy: Target lesion for ISR must be in-stent restenosis of a previously-treated lesion located in a native coronary artery with visually estimated stenosis ≥75% and <100%.). Coronary anatomy is likely to allow delivery of an investigational device to the lesions. Target lesion must be successfully pre-dilated. Planned treatment of 2 coronary artery lesions in 2 vessels may be treated (For SV trial, up to two lesions per vessel can be treated. For ISR substudy, single lesion per vessel can be treated.). Exclusion Criteria: Subject has had an acute myocardial infarction within 72 hours prior to the index procedure. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina. Subject has severe left ventricular dysfunction with ejection fraction <30%. Subject has received an organ transplant or is on a waiting list for an organ transplant. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure. Subject has renal failure with a serum creatinine of > 2.0mg/dL or who is receiving dialysis or chronic immunosuppressant therapy. Subjects has one of the following. Not expected to live for the duration of the study (1 year) by investigator's discretion due to other serious medical illness. Current problems with substance abuse. Planned procedure that may cause non-compliance with the protocol or confound data interpretation. Planned PCI (including staged procedures) or CABG after the index procedure. Subject previously treated at any time with intravascular brachytherapy. Subject has a known allergy to contrast and/or the investigational device or protocol-required concomitant medications, iopromide, raw materials of Agent DCB and SeQuent Please DCB, P2Y12 inhibitor or aspirin). Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3. Subject has a white blood cell (WBC) count < 3,000 cells/mm3. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding. Target vessel has been treated with Paclitaxel Eluting Stent or Balloon prior to the index procedure. Target vessel has been treated with any type of PCI within 6 months prior to the index procedure. Target vessel requires the use of adjunctive primary treatment modalities immediately prior to investigational device's treatment. Non-target vessel has been treated with any type of PCI within 24 hours prior to the index procedure. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint. Subject intends to participate in another investigational drug or device clinical trial within 6 months after the index procedure. Subject with known intention to procreate within 6 months after the index procedure. Subject is a woman who is pregnant or nursing. Target lesion meets any of the following criteria: Left main location. Located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate. > 50% stenosis of an additional lesion proximal or distal to the target lesion (by visual estimate). Located within a saphenous vein graft or an arterial graft. Will be accessed via a saphenous vein graft or an arterial graft. Involves a complex bifurcation (e.g., bifurcations requiring treatment with more than 1 stent). TIMI flow 0 (total occlusion) prior to wire crossing. Excessive tortuosity proximal to or within the lesion. Extreme angulation proximal to or within the lesion. Target lesion and/or target vessel proximal to the lesion is severely calcified by visual estimate to expect sub-optimal balloon expansion. Target lesion and/or target vessel adjacent to the target lesion presents with dissection or aneurysm by visual estimate. Restenosis from previous intervention (This is applicable only to SV trial.). PCI within 10 mm proximal or distal to the target lesion (by visual estimate) at any time prior to the index procedure (This is applicable only to SV trial.). Planned treatment of a single lesion with more than 1 investigational device. In-stent restenosis due to stent fracture or recoil (This is applicable only to ISR substudy.). Non-target lesion to be treated during the index procedure meets any of the following criteria: Located in the target vessel (This is applicable only to ISR substudy.). Located within a bypass graft (venous or arterial). Left main location. Chronic total occlusion. Involves a complex bifurcation. Located within 15 mm of the proximal or distal shoulder of the target lesion by visual estimate in the case of the same vessel with a target lesion for SV trial. Subject has unprotected left main coronary artery disease (>50% diameter stenosis). Thrombus, or possible thrombus, present in the target vessel. Subject with known coronary artery spasm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masato Nakamura, MD
Organizational Affiliation
Toho University Ohashi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Sapporo Higashi Tokushukai Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
065-0033
Country
Japan
Facility Name
Japan Labour Health and Welfare Organization Kanto Rosai Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-8510
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Ofuna
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
Saiseikai Yokohama-City Eastern Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
230-8765
Country
Japan
Facility Name
Sendai Kousei Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Osaka Saiseikai Nakatsu Hospital
City
Kita
State/Province
Osaka
ZIP/Postal Code
530-0012
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Meguro
State/Province
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa-Ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Kyoto-Katsura Hospital
City
Kyoto
ZIP/Postal Code
615-8256
Country
Japan
Facility Name
Miyazaki Medical Association Hospital
City
Miyazaki
ZIP/Postal Code
880-0834
Country
Japan
Facility Name
Sakurabashi Watanabe Hospital
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The confidentiality of records/data obtained in the trial will remain anonymous for analysis and publication. The information and data, obtained from the trial is used without personal identification.

Learn more about this trial

Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)

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