ABSORB STEMI: the TROFI II Study

Acute ST Segment Elevation Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986803
• Other study ID #: ECRI-003
• Status: Completed
• Phase: N/A
• Start date: January 6, 2014
• Est. completion date: September 21, 2017

Study information

• Verified date: July 2018
• Source: ECRI bv
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: September 21, 2017
• Est. primary completion date: April 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute ST Segment Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Device:
• Percutaneous Coronary Intervention
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.

Locations

Country	Name	City	State
Denmark	Research centre Aarhus, DK003	Aarhus
Denmark	Research centre Odense, DK002	Odense
Netherlands	Research centre Leeuwarden, NL002	Leeuwarden
Netherlands	Research centre Nieuwegein, NL014	Nieuwegein
Spain	Research centre Barcelona, ES001	Barcelona
Spain	Research centre Barcelona, ES003	Barcelona
Spain	Research centre Vigo, ES004	Vigo
Switzerland	Research centre Bern, CH006	Bern

Sponsors (3)

Lead Sponsor	Collaborator
ECRI bv	Abbott Vascular, Terumo Europe N.V.

Countries where clinical trial is conducted

Denmark,  Netherlands,  Spain,  Switzerland, 

Outcome

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

External Links

•   Primary endpoint manuscript (PUBMED ID: 26405232)