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

Abbott Medical Devices1,800 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,800

Conditions

Chronic Total Occlusion of Coronary Artery Coronary Occlusion Coronary Artery Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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).

Time frame: 0 to 407 days

Secondary Outcomes

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.

Time frame: < 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.

Time frame: During the hospital stay with a maximum of 3 days post index procedure

Acute Scaffold Thrombosis

Time frame: <1 day

Subacute ScaffoldThrombosis

Time frame: 1 to 30 days

Late Scaffold Thrombosis

Time frame: 31 to 365 Days

All Death, All MI, All Revascularization (DMR)

Time frame: 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).

Time frame: 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).

Time frame: 0 to 7 days (In-hospital)

Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))

Time frame: 0 to 7 days (In-hospital)

Cardiac Death/All MI

Time frame: 0 to 7 days (In-hospital)

All Death/All MI

Time frame: 0 to 7 days (In-hospital)

All Death, All MI, All Revascularization (DMR)

Time frame: 0 to 37 days

Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)

Time frame: 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).

Time frame: 0 - 37 Days

Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))

Time frame: 0 to 37 Days

Cardiac Death/All MI

Time frame: 0 to 37 days

All Death/All MI

Time frame: 0 to 37 days

All Death, All MI, All Revascularization (DMR)

Time frame: 0 to 180 days

Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)

Time frame: 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).

Time frame: 0 to 180 Days

Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))

Time frame: 0 to 180 Days

Cardiac Death/All MI

Time frame: 0 to 180 days

All Death/All MI

Time frame: 0 to 180 days

All Death, All MI, All Revascularization (DMR)

Time frame: 0 to 407 days

Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)

Time frame: 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).

Time frame: 0 to 407 Days

Cardiac Death/All MI

Time frame: 0 to 407 days

All Death/All MI

Time frame: 0 to 407 days

Death (Cardiovascular, Non-Cardiovascular)

This is one of the Safety Component (non-hierarchical) endpoints.

Time frame: 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.

Time frame: 0 to 7 days (In-hospital)

Target Lesion Revascularization (TLR): All TLR

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 7 days (In-hospital)

Target Lesion Revascularization : Ischemia-Driven (ID-TLR)

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 7 days (In-hospital)

Target Vessel Revascularization (TVR): All TVR

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 7 days (In-hospital)

Target Vessel Revascularization : Ischemic-driven (ID-TVR)

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 7 days (In-hospital)

All Revascularization

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 7 days (In-hospital)

Death (Cardiovascular, Non-Cardiovascular)

This is one of the Safety Component (non-hierarchical) endpoints.

Time frame: 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.

Time frame: 0 to 37 days

Target Lesion Revascularization (TLR): All TLR

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 37 days

Target Lesion Revascularization : Ischemia-Driven (ID-TLR)

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 37 days

Target Vessel Revascularization (TVR): All TVR

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 37 days

Target Vessel Revascularization : Ischemic-driven (ID-TVR)

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 37 days

All Revascularization

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 37 days

Death (Cardiovascular, Non-Cardiovascular)

This is one of the Safety Component (non-hierarchical) endpoints.

Time frame: 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.

Time frame: 0 to 180 days

Target Lesion Revascularization (TLR): All TLR

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 180 days

Target Lesion Revascularization : Ischemia-Driven (ID-TLR)

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 180 days

Target Vessel Revascularization (TVR): All TVR

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 180 days

Target Vessel Revascularization : Ischemic-driven (ID-TVR)

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 180 days

All Revascularization

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 180 days

Death (Cardiovascular, Non-Cardiovascular)

This is one of the Safety Component (non-hierarchical) endpoints.

Time frame: 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.

Time frame: 0 to 407 days

Target Lesion Revascularization (TLR): All TLR

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 407 days

Target Lesion Revascularization : Ischemia-Driven (ID-TLR)

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 407 days

Target Vessel Revascularization (TVR): All TVR

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 407 days

Target Vessel Revascularization : Ischemic-driven (ID-TVR)

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 407 days

All Revascularization

This is one of the Efficacy Component (non-hierarchical) endpoints.

Time frame: 0 to 407 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes