ABSORB STEMI: the TROFI II Study

Not Applicable

Completed

• Conditions: Acute ST Segment Elevation Myocardial Infarction
• Interventions: Device: Percutaneous Coronary Intervention

• Registration Number: NCT01986803
• Lead Sponsor: ECRI bv

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 Timeline

• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-11-16
• Study First Posted: 2013-11-19
• Study Start: 2014-01-06
• Primary Completion: 2015-04-13
• Study Completion: 2017-09-21
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

1. Subject must be at least 18 years of age;
2. Primary PCI within 24 hours of symptom onset;
3. 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;
4. 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;
5. 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

1. Inability to provide informed consent;
2. Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization;
3. Known intolerance to aspirin, heparin, PLLA (poly(L-lactic acid), everolimus, contrast material;
4. Cardiogenic Shock;
5. Unprotected left main coronary artery stenosis;
6. Distal occlusion of target vessel;
7. Acute myocardial infarction secondary to stent thrombosis;
8. Mechanical complications of acute myocardial infarction;
9. 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;
10. Fibrinolysis prior to PCI;
11. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy;
12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCI with XIENCE Xpedition stent	Percutaneous Coronary Intervention	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)
PCI with ABSORBTM bioresorbable vascular scaffold system (BVS)	Percutaneous Coronary Intervention	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)

Primary Outcome Measures

Name	Time	Method
Healing Score	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 Outcome Measures

Name	Time	Method
Neointimal hyperplasia area/volume	6-months	OFDI endpoint. Neointimal hyperplasia area/volume at 6-months follow-up.
Procedure success	Study patients will be followed for the duration of hospital stay (e.g. until hospital discharge), an expected average of 2 days.	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.
Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints	Up to 3 years	Clinical Endpoint.
Scaffold/Stent thrombosis according to ARC definitions at all timepoints	Up to 3 years	Clinical Endpoint. ARC = academic research consortium
Non Ischemia-driven target lesion revascularization (TLR) at all timepoints	Up to 3 years	Clinical Endpoint.
Percent diameter stenosis (%DS)	Up to 6-months	Angiographic endpoint. Percent diameter stenosis (%DS)at in in-segment (target lesion), in-device, proximal and distal
Presence of uncovered struts alone(%N)	6-months	OFDI endpoint. Presence of both uncovered struts of the index stent, which is an individual component of the primary endpoint "Healing Score".
Device-Oriented Composite Endpoint	Up to 6 months	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.
Late loss of the target lesion	Up to 6-months	Angiographic endpoint. Late loss (LL), which is decrease in blood vessel lumen diameter, at in in-segment (target lesion), in-device, proximal and distal
Angiographic binary restenosis (ABR)	Up to 6-months	Angiographic endpoint. Angiographic binary restenosis (ABR)at in in-segment (target lesion), in-device, proximal and distal
Presence of malapposed struts alone(%M)	6-months	OFDI endpoint. Presence of both malapposed struts of the index stent, which is an individual component of the primary endpoint "Healing Score".
Mean/maximal thickness of the struts coverage	6-months	OFDI endpoint. Mean/maximal thickness of the struts coverage at 6-months follow-up.
Mean Flow area/volume	6-months	OFDI endpoint. Mean Flow area/volume at 6-months follow-up.
Cardiac Death	Up to 3 years	Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Clinically-indicated target lesion revascularization	Up to 3 years	Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
All-cause death at all timepoints	Up to 3 years	Clinical Endpoint.
Any Myocardial Infarction at all timepoints	Up to 3 years	Clinical Endpoint.
Other Serious Adverse Events at all timepoints	Up to 3 years	Clinical Endpoint.
Minimal Lumen Diameter(MLD)	Up to 6-months	Angiographic endpoint. Minimal Lumen Diameter(MLD)at in in-segment (target lesion), in-device, proximal and distal
Presence of filling defect (%ILD)	6-months	OFDI endpoint. Presence of filling defect (%ILD), which is an individual component of the primary endpoint "Healing Score".
Incomplete strut apposition (ISA) area/volume	6-months	OFDI endpoint. Incomplete strut apposition (ISA) area/volume at 6-months follow-up.
Percentage of covered struts	6-months	OFDI endpoint. Percentage of covered struts at 6-months follow-up.
MI not clearly attributable to a non-intervention vessel	Up to 3 years	Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Presence of both malapposed and uncovered struts (%MN)	6-months	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".
Mean/minimal scaffold/stent diameter/area/volume	6-months	OFDI endpoint. Mean/minimal scaffold/stent diameter/area/volume at 6-months follow-up.
Mean/minimal lumen diameter/area/volume	6-months	OFDI endpoint. Mean/minimal lumen diameter/area/volume at 6-months follow-up.
Angina Class at all timepoints	Up to 3 years	Clinical Endpoint. Angina Pectoris
Intraluminal defect area/volume	6-months	OFDI endpoint. Intraluminal defect area/volume at 6-months follow-up.
Thickness of neointimal tissue developed over lipid rich plaque	6-months	OFDI endpoint. Thickness of neointimal tissue developed over lipid rich plaque at 6-months follow-up.

Trial Locations

Locations (8)

Research centre Odense, DK002; 🇩🇰 Odense, Denmark

Research centre Aarhus, DK003; 🇩🇰 Aarhus, Denmark

Research centre Leeuwarden, NL002; 🇳🇱 Leeuwarden, 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

Research centre Nieuwegein, NL014; 🇳🇱 Nieuwegein, Netherlands