Comparison of the ABSORBTM Everolimus Eluting Bioresorbable Vascular Scaffold System With a Drug- Eluting Metal Stent (XienceTM) in Acute ST-Elevation Myocardial Infarction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 191
- Locations
- 8
- Primary Endpoint
- Healing Score
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject must be at least 18 years of age;
- •Primary PCI within 24 hours of symptom onset;
- •ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguous anterior leads;
- •Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery within planned device deployment segment (Dmax) by visual estimation of ≥ 2.5 mm and ≤ 3.8 mm;
- •Subject agrees to not participate in any other investigational or invasive clinical study for a period of 6 months following the index procedure.
Exclusion Criteria
- •Inability to provide informed consent;
- •Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization;
- •Known intolerance to aspirin, heparin, PLLA (poly(L-lactic acid), everolimus, contrast material;
- •Cardiogenic Shock;
- •Unprotected left main coronary artery stenosis;
- •Distal occlusion of target vessel;
- •Acute myocardial infarction secondary to stent thrombosis;
- •Mechanical complications of acute myocardial infarction;
- •Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter;
- •Fibrinolysis prior to PCI;
- •Active bleeding or coagulopathy or patients at chronic anticoagulation therapy;
- •Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
Arms & Interventions
PCI with ABSORBTM bioresorbable vascular scaffold system (BVS)
All patients assigned to the experimental arm will be treated with a primary Percutaneous Coronary Intervention using the Abbott Vascular ABSORB TM everolimus eluting bioresorbable vascular scaffold system (BVS)
Intervention: Percutaneous Coronary Intervention (Device)
PCI with XIENCE Xpedition stent
All patients assigned to the experimental arm will be treated with a primary Percutaneous Coronary Intervention using the XIENCE Everolimus Eluting Coronary Stent System (XIENCE Xpedition) (commercial product)
Intervention: Percutaneous Coronary Intervention (Device)
Outcomes
Primary Outcomes
Healing Score
Time Frame: 6 months follow-up
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".
Secondary Outcomes
- Neointimal hyperplasia area/volume(6-months)
- Procedure success(Study patients will be followed for the duration of hospital stay (e.g. until hospital discharge), an expected average of 2 days.)
- Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints(Up to 3 years)
- Scaffold/Stent thrombosis according to ARC definitions at all timepoints(Up to 3 years)
- Non Ischemia-driven target lesion revascularization (TLR) at all timepoints(Up to 3 years)
- Percent diameter stenosis (%DS)(Up to 6-months)
- Presence of uncovered struts alone(%N)(6-months)
- Device-Oriented Composite Endpoint(Up to 6 months)
- Late loss of the target lesion(Up to 6-months)
- Angiographic binary restenosis (ABR)(Up to 6-months)
- Presence of malapposed struts alone(%M)(6-months)
- Mean/maximal thickness of the struts coverage(6-months)
- Mean Flow area/volume(6-months)
- Cardiac Death(Up to 3 years)
- Clinically-indicated target lesion revascularization(Up to 3 years)
- All-cause death at all timepoints(Up to 3 years)
- Any Myocardial Infarction at all timepoints(Up to 3 years)
- Other Serious Adverse Events at all timepoints(Up to 3 years)
- Minimal Lumen Diameter(MLD)(Up to 6-months)
- Presence of filling defect (%ILD)(6-months)
- Incomplete strut apposition (ISA) area/volume(6-months)
- Percentage of covered struts(6-months)
- MI not clearly attributable to a non-intervention vessel(Up to 3 years)
- Presence of both malapposed and uncovered struts (%MN)(6-months)
- Mean/minimal scaffold/stent diameter/area/volume(6-months)
- Mean/minimal lumen diameter/area/volume(6-months)
- Angina Class at all timepoints(Up to 3 years)
- Intraluminal defect area/volume(6-months)
- Thickness of neointimal tissue developed over lipid rich plaque(6-months)