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Absorb GT1 Japan PMS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03409731
Recruitment Status : Active, not recruiting
First Posted : January 24, 2018
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Angina Pectoris Coronary Artery Disease Coronary Artery Occlusion Myocardial Ischemia Device: ABSORB GT1 BVS Not Applicable

Detailed Description:

The surveillance consists of two phases as detailed below. All patients will be continuously registered in each phases.

Phase 1 (All- patients): Includes 250 patients (approximately 45 sites)

Main Purpose: To confirm the efficacy of physician training and to establish optimal training for increasing medical institutions participating in post-marketing evaluation. Procedural results will be evaluated sequentially for early feedback to the sites. Therefore, there will be no quantitative goal established to move to Phase 2. However, recommended procedure may be updated as required in order to achieve optimal acute result.

Phase 2 (All- patients): Until 2000 patients are registered (up to 200 sites) Main Purpose: To confirm safety.

Target sample size of the Surveillance is approximately 2,000 patients. Commercial sale of Absorb GT1 beyond the purpose of the Surveillance will be started if the scaffold thrombosis (ST) rate in the 2,000 patients at 3 month is 0.9% or lower (ST rates for patients with Absorb GT1).

In the ABSORB III (NCT01751906) clinical trial, 19 events of definite/probable ST reported through 1 year, and 18 of them except 1 occurred within 3 months (maximum of 78 days) post-procedure. Therefore, it is appropriate to perform interim analysis for the safety using ST rate through 3 months. The event occurred after 3 months was reported 362 days after the procedure, and the patient stopped treatment with thienopyridine antiplatelet agent on Day 356.

Both in the AVJ-301 (NCT01844284) and the ABSORB III clinical trials, ST rate through 1 year was 1.5%. In the ABSORB III clinical trial, ST rate in target lesion with Reference Vessel Diameter (RVD) ≥ 2.25 mm was 0.9%. As explained above, ST rates at 3 months and 1 year are almost similar. The half widths of the 95% confidence intervals (CI) to different sample sizes are presented in the table 2.3-1. The half width of 95% CI decreases from 0.6% to 0.4% when a sample size is increased from 1,000 to 2,000. However, further increase in the sample size does not result in significant decrease in the half width of 95% CI. Therefore, the sample size of the Surveillance was established as 2,000 patients.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System Post-marketing Surveillance (PMS)
Actual Study Start Date : December 13, 2016
Actual Primary Completion Date : May 31, 2018
Estimated Study Completion Date : January 15, 2023

Arm Intervention/treatment
Absorb GT1 BVS
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Device: ABSORB GT1 BVS
Patients receiving Absorb GT1 BVS




Primary Outcome Measures :
  1. Number of Participants With Acute Scaffold Thrombosis (ST) [ Time Frame: Day 0 ]

    Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

    Timings:

    Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation


  2. Number of Participants With Sub Acute Scaffold Thrombosis (ST) [ Time Frame: >1 to 30 days ]

    Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

    Timings:

    Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation


  3. Number of Participants With Late Scaffold Thrombosis (ST) [ Time Frame: 31 to 90 days ]

    Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

    Timings:

    Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation


  4. Number of Participants With Cumulative Scaffold Thrombosis [ Time Frame: 0 to 90 days ]

    Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

    Timings:

    Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation


  5. Number of Participants With Composite of Device Deficiencies [ Time Frame: During index procedure ]

    Device deficiencies: Number of participants with at least one of the following Device deficiencies

    1. Lesion/implant failure
    2. Delivery difficulty (finally delivered)
    3. Re-crossing failure
    4. Re-crossing difficulty
    5. Post-dilatation balloon
    6. Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS)
    7. Instruction for Use (IFU) not included
    8. Major Strut Malapposition
    9. Strut Fracture within 6 months


Secondary Outcome Measures :
  1. Number of Cardiac Death/Myocardial Infarction (MI) [ Time Frame: 0 to 30 days ]
    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  2. Number of Cardiac Death/Myocardial Infarction (MI) [ Time Frame: 0 to 90 days ]
    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  3. Number of All Death (Cardiac, Vascular, Non-Cardiovascular) [ Time Frame: 0 to 30 days ]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.


  4. Number of All Death (Cardiac, Vascular, Non-Cardiovascular) [ Time Frame: 0 to 90 days ]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.


  5. Number of Cardiac Death [ Time Frame: 0 to 30 days ]
    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

  6. Number of Cardiac Death [ Time Frame: 0 to 90 days ]
    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  7. Number of Participants With All Myocardial Infarction (MI) [ Time Frame: 0 to 30 days ]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)


  8. Number of Participants With All Myocardial Infarction (MI) [ Time Frame: 0 to 90 days ]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)


  9. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [ Time Frame: 0 to 30 days ]
    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  10. Number of Participants With Target Vessel Myocardial Infarction (TV-MI) [ Time Frame: 0 to 90 days ]
    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

  11. Number of Participants With All Target Lesion Revascularization (TLR) [ Time Frame: 0 to 30 days ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  12. Number of Participants With All Target Lesion Revascularization (TLR) [ Time Frame: 0 to 90 days ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  13. Number of Participants With Ischemic-Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 30 days ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  14. Number of Participants With Ischemic-Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 90 days ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  15. Number of Participants With All Target Vessel Revascularization (TVR) [ Time Frame: 0 to 30 days ]
    Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  16. Number of Participants With All Target Vessel Revascularization (TVR) [ Time Frame: 0 to 90 days ]
    Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  17. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 30 days ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  18. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 90 days ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  19. Number of Participants With All Coronary Revascularization [ Time Frame: 0 to 30 days ]
    Coronary revascularization attributed to either Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)

  20. Number of Participants With All Coronary Revascularization [ Time Frame: 0 to 90 days ]
    Coronary revascularization attributed to either Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)

  21. Number of Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 0 to 30 days ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  22. Number of Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 0 to 90 days ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  23. Number of Death/MI/All Revascularization (DMR) [ Time Frame: 0 to 30 days ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

  24. Number of Death/MI/Any Revascularization (DMR) [ Time Frame: 0 to 90 days ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • General Percutaneous coronary intervention (PCI) population.

Exclusion Criteria:

  • No specific exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409731


Locations
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Japan
Nagoya Daini Red Cross Hospital
Nagoya, Aichi, Japan, 466-8650
Shin Tokyo
Matsudo, Chiba, Japan, 270-2232
Shin Koga Hospital
Kurume, Fukuoka, Japan, 830-8577
Hanaoka Seishu Memorial Cardiovascular Clinic
Sapporo, Hokkaido, Japan, 062-0003
Kobe University
Kobe, Hyogo, Japan, 650-0017
Iwate Medical University
Morioka, Iwate, Japan, 020-8505
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan, 247-8533
Kurashiki Central Hospital
Kurashiki, Okayama, Japan, 710-8602
Saitama Sekishinkai
Sayama, Saitama, Japan, 350-1323
Mitsui Memorial Museum
Chiyoda, Tokyo, Japan, 101-8643
Teikyo University
Itabashi, Tokyo, Japan, 173-8606
Toho University Ohashi Medical Center
Meguro, Tokyo, Japan, 153-8515
Saiseikai Kumamoto Hospital
Kumamoto, Japan, 861-4193
Miyazaki Medical Association Hospital
Miyazaki, Japan, 880-0834
Sakurabashi Watanabe Hospital
Osaka, Japan, 530-0001
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Masato Nakamura, MD Toho University Ohashi Medical Hospital
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Study Protocol  [PDF] November 8, 2016
Statistical Analysis Plan  [PDF] February 17, 2017


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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03409731     History of Changes
Other Study ID Numbers: 16-310
First Posted: January 24, 2018    Key Record Dates
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Abbott Medical Devices:
Drug eluting Bio-resolvable Scaffold (BRS)
Bio-resolvable Scaffold (BRS)
Real world

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Angina Pectoris
Coronary Occlusion
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms