ABSORB STEMI: the TROFI II Study

Not Applicable

Completed

• Conditions: Acute ST Segment Elevation Myocardial Infarction

• 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

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 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