Clinical trial NCT01759290: ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.
Official title: 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Total Occlusion of Coronary Artery
Coronary Occlusion
Coronary Artery Disease
Coronary Artery Restenosis
Coronary Artery Stenosis
Coronary Disease
Coronary Restenosis
Keywords: Angioplasty
Bioabsorbable
Bioresorbable
BVS
Coronary Artery Endothelial Responsiveness
Coronary Scaffold
Coronary Stent
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-01-03
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
timeFrame: 0 to 407 days
Secondary outcomes:
measure: Acute Success: Clinical Device Success (Lesion Level Analysis)
timeFrame: < or = 1 day
measure: Acute Success: Clinical Procedure Success (Per Subject Analysis)
timeFrame: During the hospital stay with a maximum of 3 days post index procedure
measure: Acute Scaffold Thrombosis
timeFrame: <1 day
measure: Subacute ScaffoldThrombosis
timeFrame: 1 to 30 days
measure: Late Scaffold Thrombosis
timeFrame: 31 to 365 Days
measure: All Death, All MI, All Revascularization (DMR)
timeFrame: 0 to 7 days (In-hospital)
measure: Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
timeFrame: 0 to 7 days (In-hospital)
measure: Major Adverse Cardiac Event (MACE)
timeFrame: 0 to 7 days (In-hospital)
measure: Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
timeFrame: 0 to 7 days (In-hospital)
measure: Cardiac Death/All MI
timeFrame: 0 to 7 days (In-hospital)
measure: All Death/All MI
timeFrame: 0 to 7 days (In-hospital)
measure: All Death, All MI, All Revascularization (DMR)
timeFrame: 0 to 37 days
measure: Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
timeFrame: 0 to 37 days
measure: Major Adverse Cardiac Event (MACE)
timeFrame: 0 - 37 Days
measure: Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
timeFrame: 0 to 37 Days
measure: Cardiac Death/All MI
timeFrame: 0 to 37 days
measure: All Death/All MI
timeFrame: 0 to 37 days
measure: All Death, All MI, All Revascularization (DMR)
timeFrame: 0 to 180 days
measure: Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
timeFrame: 0 to 180 days
measure: Major Adverse Cardiac Event (MACE)
timeFrame: 0 to 180 Days
measure: Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
timeFrame: 0 to 180 Days
measure: Cardiac Death/All MI
timeFrame: 0 to 180 days
measure: All Death/All MI
timeFrame: 0 to 180 days
measure: All Death, All MI, All Revascularization (DMR)
timeFrame: 0 to 407 days
measure: Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
timeFrame: 0 to 407 days
measure: Major Adverse Cardiac Event (MACE)
timeFrame: 0 to 407 Days
measure: Cardiac Death/All MI
timeFrame: 0 to 407 days
measure: All Death/All MI
timeFrame: 0 to 407 days
measure: Death (Cardiovascular, Non-Cardiovascular)
timeFrame: 0 to 7 days (In-hospital)
measure: All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
timeFrame: 0 to 7 days (In-hospital)
measure: Target Lesion Revascularization (TLR): All TLR
timeFrame: 0 to 7 days (In-hospital)
measure: Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
timeFrame: 0 to 7 days (In-hospital)
measure: Target Vessel Revascularization (TVR): All TVR
timeFrame: 0 to 7 days (In-hospital)
measure: Target Vessel Revascularization : Ischemic-driven (ID-TVR)
timeFrame: 0 to 7 days (In-hospital)
measure: All Revascularization
timeFrame: 0 to 7 days (In-hospital)
measure: Death (Cardiovascular, Non-Cardiovascular)
timeFrame: 0 to 37 days
measure: All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
timeFrame: 0 to 37 days
measure: Target Lesion Revascularization (TLR): All TLR
timeFrame: 0 to 37 days
measure: Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
timeFrame: 0 to 37 days
measure: Target Vessel Revascularization (TVR): All TVR
timeFrame: 0 to 37 days
measure: Target Vessel Revascularization : Ischemic-driven (ID-TVR)
timeFrame: 0 to 37 days
measure: All Revascularization
timeFrame: 0 to 37 days
measure: Death (Cardiovascular, Non-Cardiovascular)
timeFrame: 0 to 180 days
measure: All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
timeFrame: 0 to 180 days
measure: Target Lesion Revascularization (TLR): All TLR
timeFrame: 0 to 180 days
measure: Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
timeFrame: 0 to 180 days
measure: Target Vessel Revascularization (TVR): All TVR
timeFrame: 0 to 180 days
measure: Target Vessel Revascularization : Ischemic-driven (ID-TVR)
timeFrame: 0 to 180 days
measure: All Revascularization
timeFrame: 0 to 180 days
measure: Death (Cardiovascular, Non-Cardiovascular)
timeFrame: 0 to 407 days
measure: All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
timeFrame: 0 to 407 days
measure: Target Lesion Revascularization (TLR): All TLR
timeFrame: 0 to 407 days
measure: Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
timeFrame: 0 to 407 days
measure: Target Vessel Revascularization (TVR): All TVR
timeFrame: 0 to 407 days
measure: Target Vessel Revascularization : Ischemic-driven (ID-TVR)
timeFrame: 0 to 407 days
measure: All Revascularization
timeFrame: 0 to 407 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Abbott Vascular International BVBA
Study officials:
affiliation: Fortis Escorts Heart Institute, New Delhi
name: Ashok Seth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Vaudois
name: Eric Eeckhout, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott Medical Devices
name: Peter Staehr, MD
role: STUDY_DIRECTOR
affiliation: Clinical Science
name: Vivian Mao, MD, MPH
role: STUDY_DIRECTOR
References: