To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.

Detailed Description
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ABSORB UK registry is a prospective, single arm, post-market registry designed to: Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb Everolimus Eluting BVS System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use). 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.

Official Title
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A Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb BVS

Conditions
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Coronary Disease, Coronary Artery Disease, Coronary Restenosis

Intervention / Treatment
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* Device: Absorb BVS


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 BVS<br>Subjects receiving Absorb BVS | Device: Absorb BVS<br>* The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating [formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating].<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Success: Device success (lesion based analysis) | 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 is considered to have failed if it did not meet the requirements of the definition for clinical device success. | From the start of index procedure to end of index procedure | 
| Acute Success: Procedural success (patient based analysis) | Achievement of a final in-scaffold diameter stenosis of < 50% by online 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. | From the start of index procedure to end of index procedure | 
| Death (Cardiovascular, Non-Cardiovascular) |  | 1 year | 
| Death (Cardiovascular, Non-Cardiovascular) |  | 3 year | 
| Myocardial Infarction (MI) | Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV) | 1 year | 
| MI | Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV) | 3 year | 
| Target Lesion Revascularization (TLR) | all TLR | 1 year | 
| TLR | all TLR | 3 year | 
| TLR | clinically indicated (ID-TLR) | 1 year | 
| TLR | ID-TLR | 3 year | 
| Target Vessel Revascularization (TVR) | all TVR | 1 year | 
| TVR | all TVR | 3 year | 
| TVR | clinically indicated (ID-TVR) | 1 year | 
| TVR | ID-TVR | 3 year | 
| Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint) |  | 1 year | 
| Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint) |  | 3 year | 
| Cardiac Death/All MI/ID-TLR (MACE) |  | 1 year | 
| Cardiac Death/All MI/ID-TLR (MACE) |  | 3 year | 
| Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)) |  | 1 year | 
| Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)) |  | 3 year | 
| Scaffold/Stent Thrombosis | acute, sub-acute, late and very late | 1 year | 
| Scaffold/Stent Thrombosis | Definite, Probable | 1 year | 
| Scaffold/Stent Thrombosis | acute, sub-acute, late and very late | 3 year | 
| Scaffold/Stent Thrombosis | Definite, Probable | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioabsorbable, Coronary Stent, Everolimus, drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis, CAD, CAOD