This is a Prospective, randomized (1:1), active control, single-blind, non-inferiority, European multicenter clinical trial. The primary objective of this study is to assess the neointimal healing score (as evaluated by intra-coronary OFDI) in patients with ST-elevation Myocardial Infarction (STEMI) and treated with Abbott Vascular ABSORB everolimus eluting bioresorbable vascular scaffold (BVS) at 6 months follow-up by comparing with a metallic drug eluting stent (XIENCE). Furthermore, the safety and feasibility of implanting ABSORB BVS in patients with STEMI is assessed. It is hypothesized that acutely and at 6 months follow-up implantation of the ABSORB fully bioresorbable everolimus-eluting scaffold is at least as safe as implantation of metallic drug-eluting stent, and that at late follow-up the ABSORB scaffold could improve the arterial healing process and potentially reduce late stent thrombosis in patients presenting with STEMI. This is a preparatory trial in anticipation of a major outcome study.
A total of 190 patients will be included in this trial, at 8-10 European sites. The primary endpoint is arterial healing at 6 month follow up. To assess the arterial healing, at 6 months follow-up all patients will undergo angiographic follow-up with OFDI investigation. To score the arterial healing, a Healing Score is used.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
191
Implanting a device ("Xience Xpedition" stent or "Abbott Vascular ABSORBTM everolimus eluting bioresorbable vascular scaffold system (BVS)" to open a diseased coronary artery by going to the coronary artery subcutaneously through the arteries from the radial or femoral artery access point.
Research centre Aarhus, DK003
Aarhus, Denmark
Research centre Odense, DK002
Odense, Denmark
Research centre Leeuwarden, NL002
Leeuwarden, Netherlands
Research centre Nieuwegein, NL014
Nieuwegein, Netherlands
Research centre Barcelona, ES001
Barcelona, Spain
Research centre Barcelona, ES003
Barcelona, Spain
Research centre Vigo, ES004
Vigo, Spain
Research centre Bern, CH006
Bern, Switzerland
Healing Score
The primary endpoint is: Healing Score at 6 months follow-up. This is measured with OFDI imaging. This Healing Score is a weighted index that combines the following parameters: 1. Presence of filling defect (%ILD) is assigned weight of "4", 2. Presence of both malapposed and uncovered struts (%MN) is assigned a weight of "3", 3. Presence of uncovered struts alone (%N) is assigned a weight of "2" and finally, 4. Presence of malapposition alone (%M) is assigned a weight of "1".
Time frame: 6 months follow-up
Procedure success
Clinical Endpoint. Procedure success is no in-hospital Device Oriented Composite Endpoint, which is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
Time frame: Study patients will be followed for the duration of hospital stay (e.g. until hospital discharge), an expected average of 2 days.
Device-Oriented Composite Endpoint
Clinical Endpoint. Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
Time frame: Up to 3 years
Cardiac Death
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time frame: Up to 6 months
Cardiac Death
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time frame: Up to 3 years
MI not clearly attributable to a non-intervention vessel
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time frame: Up to 6 months
MI not clearly attributable to a non-intervention vessel
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time frame: Up to 3 years
Clinically-indicated target lesion revascularization
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time frame: Up to 6 months
Clinically-indicated target lesion revascularization
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time frame: Up to 3 years
All-cause death at all timepoints
Clinical Endpoint.
Time frame: Up to 6 months
All-cause death at all timepoints
Clinical Endpoint.
Time frame: Up to 3 years
Any Myocardial Infarction at all timepoints
Clinical Endpoint.
Time frame: Up to 6 months
Any Myocardial Infarction at all timepoints
Clinical Endpoint.
Time frame: Up to 3 years
Non Ischemia-driven target lesion revascularization (TLR) at all timepoints
Clinical Endpoint.
Time frame: Up to 6 months
Non Ischemia-driven target lesion revascularization (TLR) at all timepoints
Clinical Endpoint.
Time frame: Up to 3 years
Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints
Clinical Endpoint.
Time frame: Up to 6 months
Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints
Clinical Endpoint.
Time frame: Up to 3 years
Scaffold/Stent thrombosis according to ARC definitions at all timepoints
Clinical Endpoint. ARC = academic research consortium
Time frame: Up to 6 months
Scaffold/Stent thrombosis according to ARC definitions at all timepoints
Clinical Endpoint. ARC = academic research consortium
Time frame: Up to 3 years
Angina Class at all timepoints
Clinical Endpoint. Angina Pectoris
Time frame: Up to 6 months
Angina Class at all timepoints
Clinical Endpoint. Angina Pectoris
Time frame: Up to 3 years
Other Serious Adverse Events at all timepoints
Clinical Endpoint.
Time frame: Up to 6 months
Other Serious Adverse Events at all timepoints
Clinical Endpoint.
Time frame: Up to 3 years
Device-Oriented Composite Endpoint
Clinical Endpoint. Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
Time frame: Up to 6 months
Percent diameter stenosis (%DS)
Angiographic endpoint. Percent diameter stenosis (%DS)at in in-segment (target lesion), in-device, proximal and distal
Time frame: Up to 6-months
Minimal Lumen Diameter(MLD)
Angiographic endpoint. Minimal Lumen Diameter(MLD)at in in-segment (target lesion), in-device, proximal and distal
Time frame: Up to 6-months
Late loss of the target lesion
Angiographic endpoint. Late loss (LL), which is decrease in blood vessel lumen diameter, at in in-segment (target lesion), in-device, proximal and distal
Time frame: Up to 6-months
Angiographic binary restenosis (ABR)
Angiographic endpoint. Angiographic binary restenosis (ABR)at in in-segment (target lesion), in-device, proximal and distal
Time frame: Up to 6-months
Presence of filling defect (%ILD)
OFDI endpoint. Presence of filling defect (%ILD), which is an individual component of the primary endpoint "Healing Score".
Time frame: 6-months
Presence of both malapposed and uncovered struts (%MN)
OFDI endpoint. Presence of both malapposed and uncovered struts (%MN)of the index stent, which is an individual component of the primary endpoint "Healing Score".
Time frame: 6-months
Presence of uncovered struts alone(%N)
OFDI endpoint. Presence of both uncovered struts of the index stent, which is an individual component of the primary endpoint "Healing Score".
Time frame: 6-months
Presence of malapposed struts alone(%M)
OFDI endpoint. Presence of both malapposed struts of the index stent, which is an individual component of the primary endpoint "Healing Score".
Time frame: 6-months
Mean/minimal scaffold/stent diameter/area/volume
OFDI endpoint. Mean/minimal scaffold/stent diameter/area/volume at 6-months follow-up.
Time frame: 6-months
Mean/minimal lumen diameter/area/volume
OFDI endpoint. Mean/minimal lumen diameter/area/volume at 6-months follow-up.
Time frame: 6-months
Incomplete strut apposition (ISA) area/volume
OFDI endpoint. Incomplete strut apposition (ISA) area/volume at 6-months follow-up.
Time frame: 6-months
Percentage of covered struts
OFDI endpoint. Percentage of covered struts at 6-months follow-up.
Time frame: 6-months
Mean/maximal thickness of the struts coverage
OFDI endpoint. Mean/maximal thickness of the struts coverage at 6-months follow-up.
Time frame: 6-months
Neointimal hyperplasia area/volume
OFDI endpoint. Neointimal hyperplasia area/volume at 6-months follow-up.
Time frame: 6-months
Mean Flow area/volume
OFDI endpoint. Mean Flow area/volume at 6-months follow-up.
Time frame: 6-months
Intraluminal defect area/volume
OFDI endpoint. Intraluminal defect area/volume at 6-months follow-up.
Time frame: 6-months
Thickness of neointimal tissue developed over lipid rich plaque
OFDI endpoint. Thickness of neointimal tissue developed over lipid rich plaque at 6-months follow-up.
Time frame: 6-months
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