Clinical trial NCT03409731: Absorb GT1 Japan PMS
Official title: Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System Post-marketing Surveillance (PMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Angina Pectoris
Coronary Artery Disease
Coronary Artery Occlusion
Myocardial Ischemia
Keywords: Drug eluting Bio-resolvable Scaffold (BRS)
Bio-resolvable Scaffold (BRS)
Real world
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-01-24
Enrollment: 135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* General Percutaneous coronary intervention (PCI) population.

Exclusion Criteria:

* No specific exclusion criteria.

Primary outcomes:
measure: Number of Participants With Acute Scaffold Thrombosis (ST)
timeFrame: Day 0
measure: Number of Participants With Sub Acute Scaffold Thrombosis (ST)
timeFrame: >1 to 30 days
measure: Number of Participants With Late Scaffold Thrombosis (ST)
timeFrame: 31 to 90 days
measure: Number of Participants With Late Scaffold Thrombosis (ST)
timeFrame: 31 to 365 days
measure: Number of Participants With Very Late Scaffold Thrombosis (ST)
timeFrame: 366 to 730 days
measure: Number of Participants With Overall Scaffold Thrombosis (ST)
timeFrame: 0 to 90 days
measure: Number of Participants With Cumulative Scaffold Thrombosis
timeFrame: 0 to 90 days
measure: Number of Participants With Cumulative Scaffold Thrombosis
timeFrame: 0 to 730 days
measure: Number of Participants With Exclusion of Very Small Vessels
timeFrame: During index procedure, "54.8 ± 27.6 min"
measure: Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging
timeFrame: During index procedure, "54.8 ± 27.6 min"
measure: Number of Participants With Composite of Device Deficiencies
timeFrame: During index procedure, "54.8 ± 27.6 min"
measure: Number of Participants With Late Scaffold Thrombosis (ST)
timeFrame: 731 - 1095 days
measure: Number of Participants With Cumulative Scaffold Thrombosis
timeFrame: 0 - 1095 days
measure: Number of Participants With Very Late Scaffold Thrombosis (ST)
timeFrame: 1096 - 1460 days
measure: Number of Participants With Cumulative Scaffold Thrombosis
timeFrame: 0 - 1460 days
measure: Number of Participants With Cumulative Scaffold Thrombosis
timeFrame: 0 - 1825 days
Secondary outcomes:
measure: Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 0 to 30 days
measure: Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 0 to 90 days
measure: Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 0 to 1 year
measure: Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 0 to 2 years
measure: Number of Participants With All Myocardial Infarction (MI)
timeFrame: 0 to 30 days
measure: Number of Participants With All Myocardial Infarction (MI)
timeFrame: 0 to 90 days
measure: Number of Participants With All Myocardial Infarction (MI)
timeFrame: 0 to 1 year
measure: Number of Participants With All Myocardial Infarction (MI)
timeFrame: 0 to 2 years
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 0 to 30 days
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 0 to 90 days
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 0 to 1 year
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 0 to 2 years
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 0 to 30 days
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 0 to 90 days
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 0 to 1 year
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 0 to 2 years
measure: Number of Participants With All Coronary Revascularization
timeFrame: 0 to 30 days
measure: Number of Participants With All Coronary Revascularization
timeFrame: 0 to 90 days
measure: Number of Participants With All Coronary Revascularization
timeFrame: 0 to 1 year
measure: Number of Participants With All Coronary Revascularization
timeFrame: 0 to 2 years
measure: Number of Death/MI/All Revascularization (DMR)
timeFrame: 0 to 30 days
measure: Number of Death/MI/All Revascularization (DMR)
timeFrame: 0 to 90 days
measure: Number of Death/MI/All Revascularization (DMR)
timeFrame: 0 to 1 year
measure: Number of Death/MI/All Revascularization (DMR)
timeFrame: 0 to 2 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 0 to 30 days
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 0 to 90 days
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 0 to 1 Year
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 0 to 2 years
measure: Number of Major Adverse Cardiac Event (MACE)
timeFrame: 0 to 30 days
measure: Number of Major Adverse Cardiac Event (MACE)
timeFrame: 0 to 90 days
measure: Number of Major Adverse Cardiac Event (MACE)
timeFrame: 0 to 1 year
measure: Number of Major Adverse Cardiac Event (MACE)
timeFrame: 0 to 2 years
measure: Number of Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 0 to 30 days
measure: Number of Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 0 to 90 days
measure: Number of Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 0 to 1 year
measure: Number of Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 0 to 2 years
measure: Number of Participants With Cardiac Death/Myocardial Infarction (MI)
timeFrame: 0 to 30 days
measure: Number of Participants With Cardiac Death/Myocardial Infarction (MI)
timeFrame: 0 to 90 days
measure: Number of Participants With Cardiac Death/Myocardial Infarction (MI)
timeFrame: 0 to 1 year
measure: Number of Participants With Cardiac Death/Myocardial Infarction (MI)
timeFrame: 0 to 2 years
measure: Angiographic Endpoints (Core Lab Analysis): Lesion Morphology
timeFrame: Pre-procedure
measure: Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow
timeFrame: Pre-procedure
measure: Angiographic Endpoints (Core Lab Analysis): Lesion Length
timeFrame: Pre-procedure
measure: Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)
timeFrame: Pre-procedure
measure: Angiographic Endpoints (Core Lab Analysis): Distal RVD
timeFrame: Pre-procedure
measure: Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD)
timeFrame: Pre-procedure
measure: Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS)
timeFrame: Pre-procedure
measure: Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow
timeFrame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
measure: Angiographic Endpoints (Core Lab Analysis): MLD (In-segment)
timeFrame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
measure: Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment )
timeFrame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
measure: Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment )
timeFrame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
measure: IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)
timeFrame: Pre-procedure (or after pre-dilatation)
measure: IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)
timeFrame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
measure: IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area
timeFrame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
measure: IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition
timeFrame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
measure: IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture
timeFrame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
measure: Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 3 years
measure: Number of Participants With All Myocardial Infarction (MI)
timeFrame: 3 years
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 3 years
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 3 years
measure: Number of Participants With All Coronary Revascularization
timeFrame: 3 years
measure: Number of Death/MI/All Revascularization (DMR)
timeFrame: 3 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 3 years
measure: Number of Major Adverse Cardiac Event (MACE)
timeFrame: 3 years
measure: Number of Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 3 years
measure: Number of Participants With Cardiac Death/Myocardial Infarction (MI)
timeFrame: 3 years
measure: Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 4 years
measure: Number of Participants With All Myocardial Infarction (MI)
timeFrame: 4 years
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 4 years
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 4 years
measure: Number of Participants With All Coronary Revascularization
timeFrame: 4 years
measure: Number of Death/MI/All Revascularization (DMR)
timeFrame: 4 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 4 years
measure: Number of Major Adverse Cardiac Event (MACE)
timeFrame: 4 years
measure: Number of Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 4 years
measure: Number of Participants With Cardiac Death/Myocardial Infarction (MI)
timeFrame: 4 years
measure: Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
timeFrame: 5 years
measure: Number of Participants With All Myocardial Infarction (MI)
timeFrame: 5 years
measure: Number of Participants With All Target Lesion Revascularization (TLR)
timeFrame: 5 years
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 5 years
measure: Number of Death/MI/All Revascularization (DMR)
timeFrame: 5 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 5 years
measure: Number of Major Adverse Cardiac Event (MACE)
timeFrame: 5 years
measure: Number of Cardiac Death/TV-MI/ID-TLR (TLF)
timeFrame: 5 years
measure: Number of Participants With Cardiac Death/Myocardial Infarction (MI)
timeFrame: 5 years
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya Daini Red Cross Hospital
state: Aichi
city: Matsudo
country: Japan
facility: Shin Tokyo Hospital
state: Chiba
city: Kurume
country: Japan
facility: Shin Koga Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hanaoka Seishu Memorial Cardiovascular Clinic
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University
state: Hyogo
city: Morioka
country: Japan
facility: Iwate Medical University
state: Iwate
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Sayama
country: Japan
facility: Saitama Sekishinkai Hospital
state: Saitama
city: Chiyoda
country: Japan
facility: Mitsui Memorial Museum
state: Tokyo
city: Itabashi
country: Japan
facility: Teikyo University
state: Tokyo
city: Meguro
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Miyazaki
country: Japan
facility: Miyazaki Medical Association Hospital
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
Study officials:
affiliation: Toho University Ohashi Medical Hospital
name: Masato Nakamura, MD
role: PRINCIPAL_INVESTIGATOR
References: