ABSORB STEMI: the TROFI II Study

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.

Official Title
-----------------
Comparison of the ABSORBTM Everolimus Eluting Bioresorbable Vascular Scaffold System With a Drug- Eluting Metal Stent (XienceTM) in Acute ST-Elevation Myocardial Infarction

Conditions
-----------------
Acute ST Segment Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Device: Percutaneous Coronary Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCI with ABSORBTM bioresorbable vascular scaffold system (BVS)<br>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) | Device: Percutaneous Coronary Intervention<br>* 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.<br>|
| Active Comparator: PCI with XIENCE Xpedition stent<br>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) | Device: Percutaneous Coronary Intervention<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Presence of filling defect (%ILD) is assigned weight of 4, Presence of both malapposed and uncovered struts (%MN) is assigned a weight of 3, Presence of uncovered struts alone (%N) is assigned a weight of 2 and finally, Presence of malapposition alone (%M) is assigned a weight of 1. | 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 3 years | 
| All-cause death at all timepoints | Clinical Endpoint. | Up to 6 months | 
| All-cause death at all timepoints | Clinical Endpoint. | Up to 3 years | 
| Any Myocardial Infarction at all timepoints | Clinical Endpoint. | Up to 6 months | 
| Any Myocardial Infarction at all timepoints | Clinical Endpoint. | Up to 3 years | 
| Non Ischemia-driven target lesion revascularization (TLR) at all timepoints | Clinical Endpoint. | Up to 6 months | 
| Non Ischemia-driven target lesion revascularization (TLR) at all timepoints | Clinical Endpoint. | Up to 3 years | 
| Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints | Clinical Endpoint. | Up to 6 months | 
| Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints | Clinical Endpoint. | Up to 3 years | 
| Scaffold/Stent thrombosis according to ARC definitions at all timepoints | Clinical Endpoint. ARC = academic research consortium | Up to 6 months | 
| Scaffold/Stent thrombosis according to ARC definitions at all timepoints | Clinical Endpoint. ARC = academic research consortium | Up to 3 years | 
| Angina Class at all timepoints | Clinical Endpoint. Angina Pectoris | Up to 6 months | 
| Angina Class at all timepoints | Clinical Endpoint. Angina Pectoris | Up to 3 years | 
| Other Serious Adverse Events at all timepoints | Clinical Endpoint. | Up to 6 months | 
| Other Serious Adverse Events at all timepoints | Clinical Endpoint. | 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. | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 6-months | 
| Mean/minimal scaffold/stent diameter/area/volume | OFDI endpoint. Mean/minimal scaffold/stent diameter/area/volume at 6-months follow-up. | 6-months | 
| Mean/minimal lumen diameter/area/volume | OFDI endpoint. Mean/minimal lumen diameter/area/volume at 6-months follow-up. | 6-months | 
| Incomplete strut apposition (ISA) area/volume | OFDI endpoint. Incomplete strut apposition (ISA) area/volume at 6-months follow-up. | 6-months | 
| Percentage of covered struts | OFDI endpoint. Percentage of covered struts at 6-months follow-up. | 6-months | 
| Mean/maximal thickness of the struts coverage | OFDI endpoint. Mean/maximal thickness of the struts coverage at 6-months follow-up. | 6-months | 
| Neointimal hyperplasia area/volume | OFDI endpoint. Neointimal hyperplasia area/volume at 6-months follow-up. | 6-months | 
| Mean Flow area/volume | OFDI endpoint. Mean Flow area/volume at 6-months follow-up. | 6-months | 
| Intraluminal defect area/volume | OFDI endpoint. Intraluminal defect area/volume at 6-months follow-up. | 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. | 6-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ST-elevation Myocardial Infarction (STEMI), Primary Percutaneous Coronary Intervention within 24 hrs, Healing score, OFDI