N/A
N=135
Absorb GT1 Japan PMS
Ischemic Heart Disease · Angina Pectoris · Coronary Artery Disease · Coronary Artery Occlusion · Myocardial Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT03409731 ↗Enrolled (actual)
135
Serious AEs
31.9%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Acute Scaffold Thrombosis (ST) — 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ABSORB GT1 BVS (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Scaffold Thrombosis (ST) |
0; 0; 0 | — |
| PRIMARY Number of Participants With Sub Acute Scaffold Thrombosis (ST) |
0; 0; 0 | — |
| PRIMARY Number of Participants With Late Scaffold Thrombosis (ST) |
0; 0; 0 | — |
| PRIMARY Number of Participants With Late Scaffold Thrombosis (ST) |
0; 0; 0 | — |
| PRIMARY Number of Participants With Very Late Scaffold Thrombosis (ST) |
0; 0; 0 | — |
| PRIMARY Number of Participants With Overall Scaffold Thrombosis (ST) |
0; 0; 0 | — |
| PRIMARY Number of Participants With Cumulative Scaffold Thrombosis |
0; 0; 0 | — |
| PRIMARY Number of Participants With Cumulative Scaffold Thrombosis |
0; 0; 0 | — |
| PRIMARY Number of Participants With Exclusion of Very Small Vessels |
18; 26; 91; 4 | — |
| PRIMARY Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging |
5 | — |
| PRIMARY Number of Participants With Composite of Device Deficiencies |
0; 6; 1; 0; 11; 1 | — |
| PRIMARY Number of Participants With Late Scaffold Thrombosis (ST) |
0; 0; 0 | — |
| PRIMARY Number of Participants With Cumulative Scaffold Thrombosis |
0; 0; 0 | — |
| PRIMARY Number of Participants With Very Late Scaffold Thrombosis (ST) |
0; 0; 0 | — |
| PRIMARY Number of Participants With Cumulative Scaffold Thrombosis |
0; 0; 0 | — |
| PRIMARY Number of Participants With Cumulative Scaffold Thrombosis |
0; 0; 0 | — |
| SECONDARY Number of All Death (Cardiac, Vascular, Non-Cardiovascular) |
4 | — |
| SECONDARY Number of All Death (Cardiac, Vascular, Non-Cardiovascular) |
4 | — |
| SECONDARY Number of All Death (Cardiac, Vascular, Non-Cardiovascular) |
4 | — |
| SECONDARY Number of All Death (Cardiac, Vascular, Non-Cardiovascular) |
4 | — |
| SECONDARY Number of Participants With All Myocardial Infarction (MI) |
2 | — |
| SECONDARY Number of Participants With All Myocardial Infarction (MI) |
2 | — |
| SECONDARY Number of Participants With All Myocardial Infarction (MI) |
2 | — |
| SECONDARY Number of Participants With All Myocardial Infarction (MI) |
2 | — |
| SECONDARY Number of Participants With All Target Lesion Revascularization (TLR) |
6 | — |
| SECONDARY Number of Participants With All Target Lesion Revascularization (TLR) |
6 | — |
| SECONDARY Number of Participants With All Target Lesion Revascularization (TLR) |
6 | — |
| SECONDARY Number of Participants With All Target Lesion Revascularization (TLR) |
6 | — |
| SECONDARY Number of Participants With All Target Vessel Revascularization (TVR) |
11 | — |
| SECONDARY Number of Participants With All Target Vessel Revascularization (TVR) |
11 | — |
| SECONDARY Number of Participants With All Target Vessel Revascularization (TVR) |
11 | — |
| SECONDARY Number of Participants With All Target Vessel Revascularization (TVR) |
11 | — |
| SECONDARY Number of Participants With All Coronary Revascularization |
16 | — |
| SECONDARY Number of Participants With All Coronary Revascularization |
16 | — |
| SECONDARY Number of Participants With All Coronary Revascularization |
16 | — |
| SECONDARY Number of Participants With All Coronary Revascularization |
16 | — |
| SECONDARY Number of Death/MI/All Revascularization (DMR) |
23 | — |
| SECONDARY Number of Death/MI/All Revascularization (DMR) |
23 | — |
| SECONDARY Number of Death/MI/All Revascularization (DMR) |
23 | — |
| SECONDARY Number of Death/MI/All Revascularization (DMR) |
23 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
11 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
11 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
11 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
11 | — |
| SECONDARY Number of Major Adverse Cardiac Event (MACE) |
7 | — |
| SECONDARY Number of Major Adverse Cardiac Event (MACE) |
7 | — |
| SECONDARY Number of Major Adverse Cardiac Event (MACE) |
7 | — |
| SECONDARY Number of Major Adverse Cardiac Event (MACE) |
7 | — |
| SECONDARY Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
6 | — |
| SECONDARY Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
6 | — |
| SECONDARY Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
6 | — |
| SECONDARY Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
6 | — |
| SECONDARY Number of Participants With Cardiac Death/Myocardial Infarction (MI) |
4 | — |
| SECONDARY Number of Participants With Cardiac Death/Myocardial Infarction (MI) |
4 | — |
| SECONDARY Number of Participants With Cardiac Death/Myocardial Infarction (MI) |
4 | — |
| SECONDARY Number of Participants With Cardiac Death/Myocardial Infarction (MI) |
4 | — |
| SECONDARY Angiographic Endpoints (Core Lab Analysis): Lesion Morphology |
51.8; 11.5; 27.3; 0.0 | — |
| SECONDARY Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow |
0.00; 0.72; 2.16; 97.12 | — |
| SECONDARY Angiographic Endpoints (Core Lab Analysis): Lesion Length |
13.84 | — |
| SECONDARY Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD) |
3.15 | — |
| SECONDARY Angiographic Endpoints (Core Lab Analysis): Distal RVD |
2.95 | — |
| SECONDARY Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD) |
1.00 | — |
| SECONDARY Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS) |
63.1 | — |
| SECONDARY Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow |
0.00; 0.72; 1.44; 97.84 | — |
| SECONDARY Angiographic Endpoints (Core Lab Analysis): MLD (In-segment) |
2.30 | — |
| SECONDARY Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment ) |
18.4 | — |
| SECONDARY Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment ) |
1.29 | — |
| SECONDARY IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) |
8.21; 6.54 | — |
| SECONDARY IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) |
8.21; 6.54 | — |
| SECONDARY IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area |
6.86 | — |
| SECONDARY IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition |
1.89 | — |
| SECONDARY IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture |
1; 138 | — |
| SECONDARY Number of All Death (Cardiac, Vascular, Non-Cardiovascular) |
4 | — |
| SECONDARY Number of Participants With All Myocardial Infarction (MI) |
2 | — |
| SECONDARY Number of Participants With All Target Lesion Revascularization (TLR) |
6 | — |
| SECONDARY Number of Participants With All Target Vessel Revascularization (TVR) |
11 | — |
| SECONDARY Number of Participants With All Coronary Revascularization |
16 | — |
| SECONDARY Number of Death/MI/All Revascularization (DMR) |
23 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
11 | — |
| SECONDARY Number of Major Adverse Cardiac Event (MACE) |
7 | — |
| SECONDARY Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
6 | — |
| SECONDARY Number of Participants With Cardiac Death/Myocardial Infarction (MI) |
4 | — |
| SECONDARY Number of All Death (Cardiac, Vascular, Non-Cardiovascular) |
4 | — |
| SECONDARY Number of Participants With All Myocardial Infarction (MI) |
2 | — |
| SECONDARY Number of Participants With All Target Lesion Revascularization (TLR) |
6 | — |
| SECONDARY Number of Participants With All Target Vessel Revascularization (TVR) |
11 | — |
| SECONDARY Number of Participants With All Coronary Revascularization |
16 | — |
| SECONDARY Number of Death/MI/All Revascularization (DMR) |
23 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
11 | — |
| SECONDARY Number of Major Adverse Cardiac Event (MACE) |
7 | — |
| SECONDARY Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
6 | — |
| SECONDARY Number of Participants With Cardiac Death/Myocardial Infarction (MI) |
4 | — |
| SECONDARY Number of All Death (Cardiac, Vascular, Non-Cardiovascular) |
4 | — |
| SECONDARY Number of Participants With All Myocardial Infarction (MI) |
2 | — |
| SECONDARY Number of Participants With All Target Lesion Revascularization (TLR) |
6 | — |
| SECONDARY Number of Participants With All Target Vessel Revascularization (TVR) |
11 | — |
| SECONDARY Number of Death/MI/All Revascularization (DMR) |
23 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
11 | — |
| SECONDARY Number of Major Adverse Cardiac Event (MACE) |
7 | — |
| SECONDARY Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
6 | — |
| SECONDARY Number of Participants With Cardiac Death/Myocardial Infarction (MI) |
4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03409731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.