ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.

Study Overview
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Brief Summary
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ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to: Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use). To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s) Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.

Detailed Description
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the ABSORB FIRST Registry is intended to provide an assessment of the safety and performance of the Absorb BVS device in accordance to the IFU in real world use involving more complex patients, lesions and use (examples: longer lesions, overlapping use, bailout, patients at high risks for cardiac events, etc.). The ABSORB FIRST study will register a minimum of 1800 patients in approximately 90 sites throughout multiple countries worldwide where Absorb BVS has regulatory approval or is commercially available.

Official Title
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ABSORB FIRST Registry: An International Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb Bioresorbable Vascular Scaffold (Absorb BVS).

Conditions
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Chronic Total Occlusion of Coronary Artery, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Restenosis, Coronary Artery Stenosis, Coronary Disease, Coronary Restenosis

Intervention / Treatment
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* Device: Absorb Bioresorbable Vascular Scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria must follow the most recent IFU which may include but are not limited to the following: Patient must be at least 18 years of age at the time of signing the Informed Consent Form Patient is to be treated for de novo lesions located in previously untreated vessels. Patient must agree to undergo all required follow-up visits and data collection. Exclusion Criteria: The exclusion criteria must follow the most recent IFU which may include but are not limited to the following: Inability to obtain a signed informed consent from potential patient. Patient belongs to a vulnerable population (per investigator's judgment, this also includes people with a direct link (hierarchical or financial benefit) to the registry Doctor or the registry Sponsor).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Absorb Bioresorbable Vascular Scaffold<br>Subjects receiving the Absorb Bioresorbable Vascular Scaffold | Device: Absorb Bioresorbable Vascular Scaffold<br>* Subjects receiving the Absorb Bioresorbable Vascular Scaffold<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 to 407 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Success: Clinical Device Success (Lesion Level Analysis) | Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of <50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success. | < or = 1 day | 
| Acute Success: Clinical Procedure Success (Per Subject Analysis) | Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of <50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure. | During the hospital stay with a maximum of 3 days post index procedure | 
| Acute Scaffold Thrombosis |  | <1 day | 
| Subacute ScaffoldThrombosis |  | 1 to 30 days | 
| Late Scaffold Thrombosis |  | 31 to 365 Days | 
| All Death, All MI, All Revascularization (DMR) |  | 0 to 7 days (In-hospital) | 
| Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 to 7 days (In-hospital) | 
| Major Adverse Cardiac Event (MACE) | MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 to 7 days (In-hospital) | 
| Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 to 7 days (In-hospital) | 
| Cardiac Death/All MI |  | 0 to 7 days (In-hospital) | 
| All Death/All MI |  | 0 to 7 days (In-hospital) | 
| All Death, All MI, All Revascularization (DMR) |  | 0 to 37 days | 
| Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 to 37 days | 
| Major Adverse Cardiac Event (MACE) | MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 - 37 Days | 
| Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 to 37 Days | 
| Cardiac Death/All MI |  | 0 to 37 days | 
| All Death/All MI |  | 0 to 37 days | 
| All Death, All MI, All Revascularization (DMR) |  | 0 to 180 days | 
| Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 to 180 days | 
| Major Adverse Cardiac Event (MACE) | MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 to 180 Days | 
| Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 to 180 Days | 
| Cardiac Death/All MI |  | 0 to 180 days | 
| All Death/All MI |  | 0 to 180 days | 
| All Death, All MI, All Revascularization (DMR) |  | 0 to 407 days | 
| Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) | Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 to 407 days | 
| Major Adverse Cardiac Event (MACE) | MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical). | 0 to 407 Days | 
| Cardiac Death/All MI |  | 0 to 407 days | 
| All Death/All MI |  | 0 to 407 days | 
| Death (Cardiovascular, Non-Cardiovascular) | This is one of the Safety Component (non-hierarchical) endpoints. | 0 to 7 days (In-hospital) | 
| All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | This is one of the Safety Component (non-hierarchical) endpoints. | 0 to 7 days (In-hospital) | 
| Target Lesion Revascularization (TLR): All TLR | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 7 days (In-hospital) | 
| Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 7 days (In-hospital) | 
| Target Vessel Revascularization (TVR): All TVR | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 7 days (In-hospital) | 
| Target Vessel Revascularization : Ischemic-driven (ID-TVR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 7 days (In-hospital) | 
| All Revascularization | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 7 days (In-hospital) | 
| Death (Cardiovascular, Non-Cardiovascular) | This is one of the Safety Component (non-hierarchical) endpoints. | 0 to 37 days | 
| All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | This is one of the Safety Component (non-hierarchical) endpoints. | 0 to 37 days | 
| Target Lesion Revascularization (TLR): All TLR | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 37 days | 
| Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 37 days | 
| Target Vessel Revascularization (TVR): All TVR | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 37 days | 
| Target Vessel Revascularization : Ischemic-driven (ID-TVR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 37 days | 
| All Revascularization | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 37 days | 
| Death (Cardiovascular, Non-Cardiovascular) | This is one of the Safety Component (non-hierarchical) endpoints. | 0 to 180 days | 
| All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | This is one of the Safety Component (non-hierarchical) endpoints. | 0 to 180 days | 
| Target Lesion Revascularization (TLR): All TLR | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 180 days | 
| Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 180 days | 
| Target Vessel Revascularization (TVR): All TVR | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 180 days | 
| Target Vessel Revascularization : Ischemic-driven (ID-TVR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 180 days | 
| All Revascularization | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 180 days | 
| Death (Cardiovascular, Non-Cardiovascular) | This is one of the Safety Component (non-hierarchical) endpoints. | 0 to 407 days | 
| All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). | This is one of the Safety Component (non-hierarchical) endpoints. | 0 to 407 days | 
| Target Lesion Revascularization (TLR): All TLR | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 407 days | 
| Target Lesion Revascularization : Ischemia-Driven (ID-TLR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 407 days | 
| Target Vessel Revascularization (TVR): All TVR | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 407 days | 
| Target Vessel Revascularization : Ischemic-driven (ID-TVR) | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 407 days | 
| All Revascularization | This is one of the Efficacy Component (non-hierarchical) endpoints. | 0 to 407 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angioplasty, Bioabsorbable, Bioresorbable, BVS, Coronary Artery Endothelial Responsiveness, Coronary Scaffold, Coronary Stent