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Completed

NCT Number: NCT01986803

ABSORB STEMI: the TROFI II Study

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.

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Key information

Conditions

Acute ST Segment Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research centre Aarhus, DK003, Aarhus, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous coronary intervention

Device

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.

Primary outcomes

  1. 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:

    • 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".

Secondary outcomes

  1. Procedure success

    Time frame: 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.

  2. Device-Oriented Composite Endpoint

    Time frame: Up to 3 years

    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.

  3. Cardiac Death

    Time frame: Up to 6 months

    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  4. Cardiac Death

    Time frame: Up to 3 years

    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  5. MI not clearly attributable to a non-intervention vessel

    Time frame: Up to 6 months

    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  6. MI not clearly attributable to a non-intervention vessel

    Time frame: Up to 3 years

    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  7. Clinically-indicated target lesion revascularization

    Time frame: Up to 6 months

    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  8. Clinically-indicated target lesion revascularization

    Time frame: Up to 3 years

    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  9. All-cause death at all timepoints

    Time frame: Up to 6 months

    Clinical Endpoint.

  10. All-cause death at all timepoints

    Time frame: Up to 3 years

    Clinical Endpoint.

  11. Any Myocardial Infarction at all timepoints

    Time frame: Up to 6 months

    Clinical Endpoint.

  12. Any Myocardial Infarction at all timepoints

    Time frame: Up to 3 years

    Clinical Endpoint.

  13. Non Ischemia-driven target lesion revascularization (TLR) at all timepoints

    Time frame: Up to 6 months

    Clinical Endpoint.

  14. Non Ischemia-driven target lesion revascularization (TLR) at all timepoints

    Time frame: Up to 3 years

    Clinical Endpoint.

  15. Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints

    Time frame: Up to 6 months

    Clinical Endpoint.

  16. Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints

    Time frame: Up to 3 years

    Clinical Endpoint.

  17. Scaffold/Stent thrombosis according to ARC definitions at all timepoints

    Time frame: Up to 6 months

    Clinical Endpoint. ARC = academic research consortium

  18. Scaffold/Stent thrombosis according to ARC definitions at all timepoints

    Time frame: Up to 3 years

    Clinical Endpoint. ARC = academic research consortium

  19. Angina Class at all timepoints

    Time frame: Up to 6 months

    Clinical Endpoint. Angina Pectoris

  20. Angina Class at all timepoints

    Time frame: Up to 3 years

    Clinical Endpoint. Angina Pectoris

  21. Other Serious Adverse Events at all timepoints

    Time frame: Up to 6 months

    Clinical Endpoint.

  22. Other Serious Adverse Events at all timepoints

    Time frame: Up to 3 years

    Clinical Endpoint.

  23. Device-Oriented Composite Endpoint

    Time frame: 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.

  24. Percent diameter stenosis (%DS)

    Time frame: Up to 6-months

    Angiographic endpoint. Percent diameter stenosis (%DS)at in in-segment (target lesion), in-device, proximal and distal

  25. Minimal Lumen Diameter(MLD)

    Time frame: Up to 6-months

    Angiographic endpoint. Minimal Lumen Diameter(MLD)at in in-segment (target lesion), in-device, proximal and distal

  26. Late loss of the target lesion

    Time frame: 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

  27. Angiographic binary restenosis (ABR)

    Time frame: Up to 6-months

    Angiographic endpoint. Angiographic binary restenosis (ABR)at in in-segment (target lesion), in-device, proximal and distal

  28. Presence of filling defect (%ILD)

    Time frame: 6-months

    OFDI endpoint. Presence of filling defect (%ILD), which is an individual component of the primary endpoint "Healing Score".

  29. Presence of both malapposed and uncovered struts (%MN)

    Time frame: 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".

  30. Presence of uncovered struts alone(%N)

    Time frame: 6-months

    OFDI endpoint. Presence of both uncovered struts of the index stent, which is an individual component of the primary endpoint "Healing Score".

  31. Presence of malapposed struts alone(%M)

    Time frame: 6-months

    OFDI endpoint. Presence of both malapposed struts of the index stent, which is an individual component of the primary endpoint "Healing Score".

  32. Mean/minimal scaffold/stent diameter/area/volume

    Time frame: 6-months

    OFDI endpoint. Mean/minimal scaffold/stent diameter/area/volume at 6-months follow-up.

  33. Mean/minimal lumen diameter/area/volume

    Time frame: 6-months

    OFDI endpoint. Mean/minimal lumen diameter/area/volume at 6-months follow-up.

  34. Incomplete strut apposition (ISA) area/volume

    Time frame: 6-months

    OFDI endpoint. Incomplete strut apposition (ISA) area/volume at 6-months follow-up.

  35. Percentage of covered struts

    Time frame: 6-months

    OFDI endpoint. Percentage of covered struts at 6-months follow-up.

  36. Mean/maximal thickness of the struts coverage

    Time frame: 6-months

    OFDI endpoint. Mean/maximal thickness of the struts coverage at 6-months follow-up.

  37. Neointimal hyperplasia area/volume

    Time frame: 6-months

    OFDI endpoint. Neointimal hyperplasia area/volume at 6-months follow-up.

  38. Mean Flow area/volume

    Time frame: 6-months

    OFDI endpoint. Mean Flow area/volume at 6-months follow-up.

  39. Intraluminal defect area/volume

    Time frame: 6-months

    OFDI endpoint. Intraluminal defect area/volume at 6-months follow-up.

  40. Thickness of neointimal tissue developed over lipid rich plaque

    Time frame: 6-months

    OFDI endpoint. Thickness of neointimal tissue developed over lipid rich plaque at 6-months follow-up.

Sponsors and collaborators

Lead sponsor

ECRI bv

Industry

Collaborators

  • Abbott Medical Devices
  • Terumo Europe N.V.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Nov 19, 2013
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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