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

Completed

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

Interventions: Device: Absorb Bioresorbable Vascular Scaffold

Registration Number: NCT01759290

Lead Sponsor: Abbott Medical Devices

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1800

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).

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Absorb Bioresorbable Vascular Scaffold	Absorb Bioresorbable Vascular Scaffold	Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Primary Outcome Measures

Name	Time	Method
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))	0 to 407 days	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).

Secondary Outcome Measures

Name	Time	Method
All Revascularization	0 to 407 days	This is one of the Efficacy Component (non-hierarchical) endpoints.
Acute Success: Clinical Device Success (Lesion Level Analysis)	< or = 1 day	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.
Acute Success: Clinical Procedure Success (Per Subject Analysis)	During the hospital stay with a maximum of 3 days post index procedure	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.
All Death, All MI, All Revascularization (DMR)	0 to 407 days
Death (Cardiovascular, Non-Cardiovascular)	0 to 407 days	This is one of the Safety Component (non-hierarchical) endpoints.
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).	0 to 407 days	This is one of the Safety Component (non-hierarchical) endpoints.
Target Lesion Revascularization (TLR): All TLR	0 to 407 days	This is one of the Efficacy Component (non-hierarchical) endpoints.
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)	0 to 407 days	This is one of the Efficacy Component (non-hierarchical) endpoints.
Acute Scaffold Thrombosis	<1 day
Late Scaffold Thrombosis	31 to 365 Days
Major Adverse Cardiac Event (MACE)	0 to 407 Days	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).
Cardiac Death/All MI	0 to 407 days
Target Vessel Revascularization (TVR): All TVR	0 to 407 days	This is one of the Efficacy Component (non-hierarchical) endpoints.
Subacute ScaffoldThrombosis	1 to 30 days
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))	0 to 180 Days	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).
All Death/All MI	0 to 407 days
Target Vessel Revascularization : Ischemic-driven (ID-TVR)	0 to 407 days	This is one of the Efficacy Component (non-hierarchical) endpoints.
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)	0 to 407 days	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).