The ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center, single-arm, non-randomized trial to evaluate the safety of the use of ABSORB in a real-world setting following commercial physician training'and to observe the effectiveness of commercial physician training on appropriate vessel sizing.
After approval of commercial use of Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System in over 75 countries as of December 31, 2015, Abbott Vascular has developed a post-approval commitment plan that includes the initiation of the ABSORB Post-Approval Clinical Study, a single-arm trial that will include approximately 2000 subjects at approximately 265 sites in the US and Canada. The objectives of ABSORB PostApproval Study are the following: * Evaluate the safety of the use of Absorb in a real world setting following commercial physician training. * Observe the effectiveness of commercial physician training on appropriate vessel sizing in the use of Absorb in a real world setting. The study design allows evaluating low frequency events, effectiveness of commercial physician training and education for very small vessels (\< 2.25 mm as assessed by quantitative coronary angiography \[QCA\]), and confirmation of generalizability of the treatment with Absorb to real-world practice. The estimated follow-up of safety and effectiveness will be 3 years. Angiographic Subgroup: Approximately the first 500 consecutive subjects implanted by operators inexperienced in the usage of Absorb GT1 BVS to receive baseline assessment of reference vessel diameter (RVD) by the angiographic core laboratory. An inexperienced operator is defined as having performed two or fewer Absorb implants prior to commercial approval. The purpose of the angiographic subgroup is to evaluate the effectiveness of training in the selection of appropriately sized coronary arteries for GT1 BVS implantation. Study staff will be notified after the procedure if the subject is in the angiographic subgroup, and instructed to send pre-procedure angiogram and supporting materials to core laboratory for assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Commercially approved Absorb GT1 BVS, herein referred to as "Absorb". * Scaffold diameters: 2.5, 3.0, and 3.5 mm * Scaffold lengths: 8, 12, 18, 23 and 28 mm Absorb is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
Baptist Health Louisville
Louisville, Kentucky, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Composite of cardiac death, myocardial infarction (CD/MI)
Myocardial infarction will be assessed per the Universal MI definition.
Time frame: 1 year
Definite/probable scaffold thrombosis (ST)
ST is assessed per the Academic Research Consortium (ARC) definite/probable definition.
Time frame: 1 year
The annual rate of definite/probable scaffold thrombosis
ST is assessed per the Academic Research Consortium (ARC) definite/probable definition.
Time frame: At 1 year post-index procedure
The annual rate of definite/probable scaffold thrombosis
ST is assessed per the Academic Research Consortium (ARC) definite/probable definition.
Time frame: Between 1 year and 2 years (366 to 730 days) post index procedure
The annual rate of definite/probable scaffold thrombosis
ST is assessed per the Academic Research Consortium (ARC) definite/probable definition.
Time frame: Between 2 years and 3 years (731 to 1095 days) post index procedure
Percentage of very small vessels (per-lesion basis)
This is the commercial Training Assessment Endpoint (Angiographic Subgroup only). Pre-procedure reference vessel diameter (RVD) \< 2.25 mm as assessed by core laboratory using quantitative coronary angiography (QCA).
Time frame: Pre-procedure (on day 0)
Death (Cardiac, Non-Cardiac)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Turkey Creek Medical Center
Knoxville, Tennessee, United States
Time frame: ≤ 7 days post index procedure (In-hospital )
Death (Cardiac, Non-Cardiac)
Time frame: 30 days
Death (Cardiac, Non-Cardiac)
Time frame: 180 days
Death (Cardiac, Non-Cardiac)
Time frame: 1 year
Death (Cardiac, Non-Cardiac)
Time frame: 2 years
Death (Cardiac, Non-Cardiac)
Time frame: 3 years
All Myocardial Infarction (All MI)
Time frame: ≤ 7 days post index procedure (In-hospital )
All Myocardial Infarction (All MI)
Time frame: 30 days
All Myocardial Infarction (All MI)
Time frame: 180 days
All Myocardial Infarction (All MI)
Time frame: 1 year
All Myocardial Infarction (All MI)
Time frame: 2 years
All Myocardial Infarction (All MI)
Time frame: 3 years
Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: ≤ 7 days post index procedure (In-hospital )
Target Lesion Revascularization (TLR)
Time frame: 30 days
Target Lesion Revascularization (TLR)
Time frame: 180 days
Target Lesion Revascularization (TLR)
Time frame: 1 year
Target Lesion Revascularization (TLR)
Time frame: 2 years
Target Lesion Revascularization (TLR)
Time frame: 3 years
Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: ≤ 7 days post index procedure (In-hospital )
Ischemia Driven TLR (ID-TLR)
Time frame: 30 days
Ischemia Driven TLR (ID-TLR)
Time frame: 180 days
Ischemia Driven TLR (ID-TLR)
Time frame: 1 year
Ischemia Driven TLR (ID-TLR)
Time frame: 2 years
Ischemia Driven TLR (ID-TLR)
Time frame: 3 years
Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: ≤ 7 days post index procedure (In-hospital )
Target Vessel Revascularization (TVR)
Time frame: 30 days
Target Vessel Revascularization (TVR)
Time frame: 180 days
Target Vessel Revascularization (TVR)
Time frame: 1 year
Target Vessel Revascularization (TVR)
Time frame: 2 years
Target Vessel Revascularization (TVR)
Time frame: 3 years
All coronary revascularization
Time frame: ≤ 7 days post index procedure (In-hospital )
All coronary revascularization
Time frame: 30 days
All coronary revascularization
Time frame: 180 days
All coronary revascularization
Time frame: 1 year
All coronary revascularization
Time frame: 2 years
All coronary revascularization
Time frame: 3 years
Scaffold thrombosis (per ARC definition)
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: Acute (0 - 24 hours post stent implantation) (Definite and Probable)
Scaffold thrombosis (per ARC definition)
Time frame: Subacute (>24 hours - 30 days post stent implantation)(Definite and Probable)
Scaffold thrombosis (per ARC definition)
Time frame: Late (30 days - 1 year post stent implantation) (Definite and Probable)
Scaffold thrombosis (per ARC definition)
Time frame: Very late (>1 year post stent implantation) (Definite and Probable)
Death/All Myocardial Infarction (MI)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Time frame: ≤ 7 days post index procedure (In-hospital )
Death/All Myocardial Infarction (MI)
Time frame: 30 days
Death/All Myocardial Infarction (MI)
Time frame: 180 days
Death/All Myocardial Infarction (MI)
Time frame: 1 year
Death/All Myocardial Infarction (MI)
Time frame: 2 years
Death/All Myocardial Infarction (MI)
Time frame: 3 years
Cardiac Death/All Myocardial Infarction (MI)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: ≤ 7 days post index procedure (In-hospital )
Cardiac Death/All Myocardial Infarction (MI)
Time frame: 30 days
Cardiac Death/All Myocardial Infarction (MI)
Time frame: 180 days
Cardiac Death/All Myocardial Infarction (MI)
Time frame: 1 year
Cardiac Death/All Myocardial Infarction (MI)
Time frame: 2 years
Cardiac Death/All Myocardial Infarction (MI)
Time frame: 3 years
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [Target vessel failure;TVF]
Time frame: ≤ 7 days post index procedure (In-hospital )
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
Time frame: 30 days
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
Time frame: 180 days
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
Time frame: 1 year
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
Time frame: 2 years
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
Time frame: 3 years
Cardiac Death/TV MI/ID-TLR (Target lesion failure;TLF)
Time frame: ≤ 7 days post index procedure (In-hospital )
Cardiac Death/TV MI/ID-TLR (TLF)
Time frame: 30 days
Cardiac Death/TV MI/ID-TLR (TLF)
Time frame: 180 days
Cardiac Death/TV MI/ID-TLR (TLF)
Time frame: 1 year
Cardiac Death/TV MI/ID-TLR (TLF)
Time frame: 2 years
Cardiac Death/TV MI/ID-TLR (TLF)
Time frame: 3 years
Death/All Myocardial Infarction (MI)/All revascularization
Time frame: ≤ 7 days post index procedure (In-hospital )
Death/All Myocardial Infarction (MI)/All revascularization
Time frame: 30 days
Death/All Myocardial Infarction (MI)/All revascularization
Time frame: 180 days
Death/All Myocardial Infarction (MI)/All revascularization
Time frame: 1 year
Death/All Myocardial Infarction (MI)/All revascularization
Time frame: 2 years
Death/All Myocardial Infarction (MI)/All revascularization
Time frame: 3 years