The target enrollment goal for the trial was to enroll 36 subjects. However due to a challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the trial was initiated in June 2011. To evaluate the following in participants undergoing coronary artery scaffolding/stenting for significant coronary artery disease: * The acute (post-implantation) effect of an implanted bioresorbable vascular scaffold (BVS) or metallic drug eluting stent (mDES) on coronary blood flow and physiological responsiveness of the target coronary artery * The long-term (2 years) effect of an implanted BVS or mDES on coronary blood flow and physiological responsiveness of the target coronary artery
* Prospective, randomized, single-blinded, multi-center clinical investigation comparing target vessel and non-intervened, self-control vessel within participants and between participants undergoing BVS or mDES deployment for the treatment of a single de novo native coronary artery lesion * The investigation will include two arms: * Study device (BVS) arm: Abbott Vascular's Everolimus-Eluting Bioresorbable Vascular Scaffold * Control device (mDES) arm: Abbott Vascular's Everolimus-Eluting XIENCE V or XIENCE PRIME
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
1
Bioabsorbable Everolimus Eluting Coronary Stent
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Austin Health
Heidelberg, Victoria, Australia
Royal Adelaide Hospital
Adelaide, Australia
Monash Medical Centre
Melbourne, Australia
Queen Elizabeth
Hong Kong, China
Maasstad Ziekenhuis
Rotterdam, Netherlands
National Heart Centre Singapore
Singapore, Singapore
Coronary artery endothelial responsiveness
Change of vessel diameter by 1) pacing, 2) hand-grip and 3) acetylcholine injection
Time frame: Post procedure
Coronary artery cross-sectional compliance and cross-sectional distensibility
Cross-sectional compliance is defined as change in area per unit change in pressure; cross-sectional distensibility is defined as compliance/diastolic cross-sectional area.
Time frame: Post procedure
Target artery endothelial shear stress distribution
Wall Shear Stress (WSS) will be determined from flow velocity and blood viscosity
Time frame: Post procedure
Wave intensity patterns in the coronary arteries
Looking at re-distribution of energy in the blood flow along the coronary artery.
Time frame: Post procedure
Systolic and diastolic coronary artery impedance
Time frame: Post procedure
Clinical device success
Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system.
Time frame: Post procedure
Clinical Procedure Success
Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system without the occurrence of ischemia driven major adverse cardiac event (MACE).
Time frame: during the hospital stay with a maximum of 7 days post index procedure.
Cardiac Death (CD)
Time frame: 180 days
Cardiac Death (CD)
Time frame: 1 year
Cardiac Death (CD)
Time frame: 2 years
Myocardial Infarction (MI)
Time frame: 180 days
Myocardial Infarction (MI)
Time frame: 1 year
Myocardial Infarction (MI)
Time frame: 2 years
Target Vessel Myocardial Infarction (TV-MI)
Time frame: 180 days
Target Vessel Myocardial Infarction (TV-MI)
Time frame: 1 year
Target Vessel Myocardial Infarction (TV-MI)
Time frame: 2 years
All Death, All MI, All Revascularization (DMR)
Time frame: 180 days
All Death, All MI, All Revascularization (DMR)
Time frame: 1 year
All Death, All MI, All Revascularization (DMR)
Time frame: 2 years
Ischemia-Driven MACE (ID-MACE)
Time frame: 180 days
Ischemia-Driven MACE (ID-MACE)
Time frame: 1 year
Ischemia-Driven MACE (ID-MACE)
Time frame: 2 years
Ischemia-Driven Target Vessel Failure (ID-TVF)
Time frame: 180 days
Ischemia-Driven Target Vessel Failure (ID-TVF)
Time frame: 1 year
Ischemia-Driven Target Vessel Failure (ID-TVF)
Time frame: 2 years
Ischemia-Driven Target Vessel Revascularization (ID-TVR)
Time frame: 180 days
Ischemia-Driven Target Vessel Revascularization (ID-TVR)
Time frame: 1 year
Ischemia-Driven Target Vessel Revascularization (ID-TVR)
Time frame: 2 years
Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)
Time frame: 180 days
Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)
Time frame: 1 year
Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)
Time frame: 2 years
Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)
Time frame: 180 days
Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)
Time frame: 1 year
Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)
Time frame: 2 years
Ischemia-Driven Target Lesion Revascularization (ID-TLR)
Time frame: 180 days
Ischemia-Driven Target Lesion Revascularization (ID-TLR)
Time frame: 1 year
Ischemia-Driven Target Lesion Revascularization (ID-TLR)
Time frame: 2 years
Scaffold/Stent thrombosis
Time frame: 180 days
Scaffold/Stent thrombosis
Time frame: 1 year
Scaffold/Stent thrombosis
Time frame: 2 years
Coronary artery endothelial responsiveness
Change of vessel diameter by 1) pacing, 2) hand-grip and 3) acetylcholine injection
Time frame: 2 years
Coronary artery cross-sectional compliance and cross-sectional distensibility
Cross-sectional compliance is defined as change in area per unit change in pressure; cross-sectional distensibility is defined as compliance/diastolic cross-sectional area.
Time frame: 2 years
Target artery endothelial shear stress distribution
Wall Shear Stress (WSS) will be determined from flow velocity and blood viscosity
Time frame: 2 years
Wave intensity patterns in the coronary arteries
Looking at re-distribution of energy in the blood flow along the coronary artery.
Time frame: 2 years
Systolic and diastolic coronary artery impedance
Time frame: 2 years
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