Absorb GT1 Japan PMS

Not Applicable

Completed

Conditions: Coronary Artery Occlusion
Ischemic Heart Disease
Coronary Artery Disease
Angina Pectoris
Myocardial Ischemia

Interventions: Device: ABSORB GT1 BVS

Registration Number: NCT03409731

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 135

Inclusion Criteria

General Percutaneous coronary intervention (PCI) population.

Exclusion Criteria

No specific exclusion criteria.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Absorb GT1 BVS	ABSORB GT1 BVS	Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Scaffold Thrombosis (ST)	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.
Number of Participants With Composite of Device Deficiencies	During index procedure, "54.8 ± 27.6 min"	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
Number of Participants With Late Scaffold Thrombosis (ST)	731 - 1095 days	Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), 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.
Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging	During index procedure, "54.8 ± 27.6 min"	IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab.
Number of Participants With Sub Acute Scaffold Thrombosis (ST)	>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.
Number of Participants With Very Late Scaffold Thrombosis (ST)	1096 - 1460 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
Number of Participants With Overall Scaffold Thrombosis (ST)	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
Number of Participants With Cumulative Scaffold Thrombosis	0 - 1825 days	Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), 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.
Number of Participants With Exclusion of Very Small Vessels	During index procedure, "54.8 ± 27.6 min"	For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD \< 2.5 mm from registration by the last half of Phase 1.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With All Myocardial Infarction (MI)	5 years	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)
Number of Participants With All Target Vessel Revascularization (TVR)	5 years	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.
Number of Participants With Target Vessel Failure (TVF)	5 years	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Angiographic Endpoints (Core Lab Analysis): Lesion Morphology	Pre-procedure
Number of Participants With All Coronary Revascularization	4 years	All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Number of Major Adverse Cardiac Event (MACE)	5 years	MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR).
Number of Cardiac Death/TV-MI/ID-TLR (TLF)	5 years	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)	5 years	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.
Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow	Pre-procedure	TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment )	Post-procedure (average procedure time of "54.8 ± 27.6 min")	Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Angiographic Endpoints (Core Lab Analysis): Lesion Length	Pre-procedure	Lesion Length (can be measured after successful post-dilatation)
Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow	Post-procedure (average procedure time of "54.8 ± 27.6 min")	TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)	Post-procedure (average procedure time of "54.8 ± 27.6 min")
IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area	Post-procedure (average procedure time of "54.8 ± 27.6 min")
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture	Post-procedure (average procedure time of "54.8 ± 27.6 min")	Strut fracture will be measured as either number or percentage post-procedure
Number of Participants With All Target Lesion Revascularization (TLR)	5 years	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.
Number of Death/MI/All Revascularization (DMR)	5 years	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)	Pre-procedure	Proximal RVD (can be measured after successful post-dilatation)
Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD)	Pre-procedure	Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen
Angiographic Endpoints (Core Lab Analysis): MLD (In-segment)	Post-procedure (average procedure time of "54.8 ± 27.6 min")	Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition	Post-procedure (average procedure time of "54.8 ± 27.6 min")	Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure
Number of Participants With Cardiac Death/Myocardial Infarction (MI)	5 years	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.
Angiographic Endpoints (Core Lab Analysis): Distal RVD	Pre-procedure	Distal RVD (can be measured after successful post-dilatation)
Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS)	Pre-procedure	Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment )	Post-procedure (average procedure time of "54.8 ± 27.6 min")	The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).

Trial Locations

Locations (15): Hanaoka Seishu Memorial Cardiovascular Clinic
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Sapporo, Hokkaido, Japan
Iwate Medical University
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Morioka, Iwate, Japan
Saitama Sekishinkai Hospital
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Sayama, Saitama, Japan
Kurashiki Central Hospital
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Kurashiki, Okayama, Japan
Teikyo University
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Itabashi, Tokyo, Japan
Toho University Ohashi Medical Center
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Meguro, Tokyo, Japan
Mitsui Memorial Museum
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Chiyoda, Tokyo, Japan
Kobe University
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Kobe, Hyogo, Japan
Shonan Kamakura General Hospital
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Kamakura, Kanagawa, Japan
Saiseikai Kumamoto Hospital
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Kumamoto, Japan
Shin Tokyo Hospital
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Matsudo, Chiba, Japan
Miyazaki Medical Association Hospital
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Miyazaki, Japan
Sakurabashi Watanabe Hospital
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Osaka, Japan
Nagoya Daini Red Cross Hospital
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Nagoya, Aichi, Japan
Shin Koga Hospital
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Kurume, Fukuoka, Japan