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

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).

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Disease; Coronary Occlusion; Chronic Total Occlusion of Coronary Artery; Coronary Restenosis; Coronary Artery Stenosis; Coronary Artery Restenosis
• Intervention / Treatment: Device: Absorb Bioresorbable Vascular Scaffold

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.

• Study Type: Observational
• Enrollment (Actual): 1800

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 0886.537.933
    • Abbott Vascular International BVBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled into this registry will be male and female patients derived from the general interventional cardiology population who satisfy the inclusion and exclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Absorb Bioresorbable Vascular Scaffold; Subjects receiving the Absorb Bioresorbable Vascular Scaffold	Device: Absorb Bioresorbable Vascular Scaffold; Subjects receiving the Absorb Bioresorbable Vascular Scaffold

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Ashok Seth, MD, Fortis Escorts Heart Institute, New Delhi; Principal Investigator: Eric Eeckhout, MD, PhD, Centre Hospitalier Universitaire Vaudois; Study Director: Vivian Mao, MD, MPH, Clinical Science

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: December 14, 2012
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (ESTIMATE): January 3, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 19, 2016
• Last Update Submitted That Met QC Criteria: August 26, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Angioplasty; Bioabsorbable; BVS; Coronary Artery Endothelial Responsiveness; Coronary Stent; Bioresorbable; Coronary Scaffold
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Coronary Disease; Coronary Occlusion; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: 12-302