Back to resultsABSORB STEMI: the TROFI II Study
Primary Purpose
Acute ST Segment Elevation Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Acute ST Segment Elevation Myocardial Infarction focused on measuring ST-elevation Myocardial Infarction (STEMI), Primary Percutaneous Coronary Intervention within 24 hrs, Healing score, OFDI
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.
Sites / Locations
- Research centre Aarhus, DK003
- Research centre Odense, DK002
- Research centre Leeuwarden, NL002
- Research centre Nieuwegein, NL014
- Research centre Barcelona, ES001
- Research centre Barcelona, ES003
- Research centre Vigo, ES004
- Research centre Bern, CH006
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PCI with ABSORBTM bioresorbable vascular scaffold system (BVS)
PCI with XIENCE Xpedition stent
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
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.
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.
Cardiac Death
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Cardiac Death
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
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.
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.
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.
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.
All-cause death at all timepoints
Clinical Endpoint.
All-cause death at all timepoints
Clinical Endpoint.
Any Myocardial Infarction at all timepoints
Clinical Endpoint.
Any Myocardial Infarction at all timepoints
Clinical Endpoint.
Non Ischemia-driven target lesion revascularization (TLR) at all timepoints
Clinical Endpoint.
Non Ischemia-driven target lesion revascularization (TLR) at all timepoints
Clinical Endpoint.
Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints
Clinical Endpoint.
Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints
Clinical Endpoint.
Scaffold/Stent thrombosis according to ARC definitions at all timepoints
Clinical Endpoint. ARC = academic research consortium
Scaffold/Stent thrombosis according to ARC definitions at all timepoints
Clinical Endpoint. ARC = academic research consortium
Angina Class at all timepoints
Clinical Endpoint. Angina Pectoris
Angina Class at all timepoints
Clinical Endpoint. Angina Pectoris
Other Serious Adverse Events at all timepoints
Clinical Endpoint.
Other Serious Adverse Events at all timepoints
Clinical Endpoint.
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.
Percent diameter stenosis (%DS)
Angiographic endpoint. Percent diameter stenosis (%DS)at in in-segment (target lesion), in-device, proximal and distal
Minimal Lumen Diameter(MLD)
Angiographic endpoint. Minimal Lumen Diameter(MLD)at in in-segment (target lesion), in-device, proximal and distal
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
Angiographic binary restenosis (ABR)
Angiographic endpoint. Angiographic binary restenosis (ABR)at in in-segment (target lesion), in-device, proximal and distal
Presence of filling defect (%ILD)
OFDI endpoint. Presence of filling defect (%ILD), which is an individual component of the primary endpoint "Healing Score".
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".
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".
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".
Mean/minimal scaffold/stent diameter/area/volume
OFDI endpoint. Mean/minimal scaffold/stent diameter/area/volume at 6-months follow-up.
Mean/minimal lumen diameter/area/volume
OFDI endpoint. Mean/minimal lumen diameter/area/volume at 6-months follow-up.
Incomplete strut apposition (ISA) area/volume
OFDI endpoint. Incomplete strut apposition (ISA) area/volume at 6-months follow-up.
Percentage of covered struts
OFDI endpoint. Percentage of covered struts at 6-months follow-up.
Mean/maximal thickness of the struts coverage
OFDI endpoint. Mean/maximal thickness of the struts coverage at 6-months follow-up.
Neointimal hyperplasia area/volume
OFDI endpoint. Neointimal hyperplasia area/volume at 6-months follow-up.
Mean Flow area/volume
OFDI endpoint. Mean Flow area/volume at 6-months follow-up.
Intraluminal defect area/volume
OFDI endpoint. Intraluminal defect area/volume at 6-months follow-up.
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.
Full Information
NCT ID
NCT01986803
First Posted
August 29, 2013
Last Updated
July 23, 2018
Sponsor
ECRI bv
Collaborators
Abbott Medical Devices, Terumo Europe N.V.
1. Study Identification
Unique Protocol Identification Number
NCT01986803
Brief Title
ABSORB STEMI: the TROFI II Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 6, 2014 (Actual)
Primary Completion Date
April 13, 2015 (Actual)
Study Completion Date
September 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ECRI bv
Collaborators
Abbott Medical Devices, Terumo Europe N.V.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST Segment Elevation Myocardial Infarction
Keywords
ST-elevation Myocardial Infarction (STEMI), Primary Percutaneous Coronary Intervention within 24 hrs, Healing score, OFDI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCI with ABSORBTM bioresorbable vascular scaffold system (BVS)
Arm Type
Experimental
Arm Description
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)
Arm Title
PCI with XIENCE Xpedition stent
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Percutaneous Coronary Intervention
Intervention Description
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 Outcome Measure Information:
Title
Healing Score
Description
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".
Time Frame
6 months follow-up
Secondary Outcome Measure Information:
Title
Procedure success
Description
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.
Time Frame
Study patients will be followed for the duration of hospital stay (e.g. until hospital discharge), an expected average of 2 days.
Title
Device-Oriented Composite Endpoint
Description
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.
Time Frame
Up to 3 years
Title
Cardiac Death
Description
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time Frame
Up to 6 months
Title
Cardiac Death
Description
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time Frame
Up to 3 years
Title
MI not clearly attributable to a non-intervention vessel
Description
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time Frame
Up to 6 months
Title
MI not clearly attributable to a non-intervention vessel
Description
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time Frame
Up to 3 years
Title
Clinically-indicated target lesion revascularization
Description
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time Frame
Up to 6 months
Title
Clinically-indicated target lesion revascularization
Description
Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.
Time Frame
Up to 3 years
Title
All-cause death at all timepoints
Description
Clinical Endpoint.
Time Frame
Up to 6 months
Title
All-cause death at all timepoints
Description
Clinical Endpoint.
Time Frame
Up to 3 years
Title
Any Myocardial Infarction at all timepoints
Description
Clinical Endpoint.
Time Frame
Up to 6 months
Title
Any Myocardial Infarction at all timepoints
Description
Clinical Endpoint.
Time Frame
Up to 3 years
Title
Non Ischemia-driven target lesion revascularization (TLR) at all timepoints
Description
Clinical Endpoint.
Time Frame
Up to 6 months
Title
Non Ischemia-driven target lesion revascularization (TLR) at all timepoints
Description
Clinical Endpoint.
Time Frame
Up to 3 years
Title
Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints
Description
Clinical Endpoint.
Time Frame
Up to 6 months
Title
Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints
Description
Clinical Endpoint.
Time Frame
Up to 3 years
Title
Scaffold/Stent thrombosis according to ARC definitions at all timepoints
Description
Clinical Endpoint. ARC = academic research consortium
Time Frame
Up to 6 months
Title
Scaffold/Stent thrombosis according to ARC definitions at all timepoints
Description
Clinical Endpoint. ARC = academic research consortium
Time Frame
Up to 3 years
Title
Angina Class at all timepoints
Description
Clinical Endpoint. Angina Pectoris
Time Frame
Up to 6 months
Title
Angina Class at all timepoints
Description
Clinical Endpoint. Angina Pectoris
Time Frame
Up to 3 years
Title
Other Serious Adverse Events at all timepoints
Description
Clinical Endpoint.
Time Frame
Up to 6 months
Title
Other Serious Adverse Events at all timepoints
Description
Clinical Endpoint.
Time Frame
Up to 3 years
Title
Device-Oriented Composite Endpoint
Description
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.
Time Frame
Up to 6 months
Title
Percent diameter stenosis (%DS)
Description
Angiographic endpoint. Percent diameter stenosis (%DS)at in in-segment (target lesion), in-device, proximal and distal
Time Frame
Up to 6-months
Title
Minimal Lumen Diameter(MLD)
Description
Angiographic endpoint. Minimal Lumen Diameter(MLD)at in in-segment (target lesion), in-device, proximal and distal
Time Frame
Up to 6-months
Title
Late loss of the target lesion
Description
Angiographic endpoint. Late loss (LL), which is decrease in blood vessel lumen diameter, at in in-segment (target lesion), in-device, proximal and distal
Time Frame
Up to 6-months
Title
Angiographic binary restenosis (ABR)
Description
Angiographic endpoint. Angiographic binary restenosis (ABR)at in in-segment (target lesion), in-device, proximal and distal
Time Frame
Up to 6-months
Title
Presence of filling defect (%ILD)
Description
OFDI endpoint. Presence of filling defect (%ILD), which is an individual component of the primary endpoint "Healing Score".
Time Frame
6-months
Title
Presence of both malapposed and uncovered struts (%MN)
Description
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".
Time Frame
6-months
Title
Presence of uncovered struts alone(%N)
Description
OFDI endpoint. Presence of both uncovered struts of the index stent, which is an individual component of the primary endpoint "Healing Score".
Time Frame
6-months
Title
Presence of malapposed struts alone(%M)
Description
OFDI endpoint. Presence of both malapposed struts of the index stent, which is an individual component of the primary endpoint "Healing Score".
Time Frame
6-months
Title
Mean/minimal scaffold/stent diameter/area/volume
Description
OFDI endpoint. Mean/minimal scaffold/stent diameter/area/volume at 6-months follow-up.
Time Frame
6-months
Title
Mean/minimal lumen diameter/area/volume
Description
OFDI endpoint. Mean/minimal lumen diameter/area/volume at 6-months follow-up.
Time Frame
6-months
Title
Incomplete strut apposition (ISA) area/volume
Description
OFDI endpoint. Incomplete strut apposition (ISA) area/volume at 6-months follow-up.
Time Frame
6-months
Title
Percentage of covered struts
Description
OFDI endpoint. Percentage of covered struts at 6-months follow-up.
Time Frame
6-months
Title
Mean/maximal thickness of the struts coverage
Description
OFDI endpoint. Mean/maximal thickness of the struts coverage at 6-months follow-up.
Time Frame
6-months
Title
Neointimal hyperplasia area/volume
Description
OFDI endpoint. Neointimal hyperplasia area/volume at 6-months follow-up.
Time Frame
6-months
Title
Mean Flow area/volume
Description
OFDI endpoint. Mean Flow area/volume at 6-months follow-up.
Time Frame
6-months
Title
Intraluminal defect area/volume
Description
OFDI endpoint. Intraluminal defect area/volume at 6-months follow-up.
Time Frame
6-months
Title
Thickness of neointimal tissue developed over lipid rich plaque
Description
OFDI endpoint. Thickness of neointimal tissue developed over lipid rich plaque at 6-months follow-up.
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P. Serruys, Prof.
Organizational Affiliation
Erasmus Medical Centre Rotterdam, the Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M. Sabaté, Dr.
Organizational Affiliation
University of Barcelona, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S. Windecker, Dr.
Organizational Affiliation
Bern University Hospital, Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research centre Aarhus, DK003
City
Aarhus
Country
Denmark
Facility Name
Research centre Odense, DK002
City
Odense
Country
Denmark
Facility Name
Research centre Leeuwarden, NL002
City
Leeuwarden
Country
Netherlands
Facility Name
Research centre Nieuwegein, NL014
City
Nieuwegein
Country
Netherlands
Facility Name
Research centre Barcelona, ES001
City
Barcelona
Country
Spain
Facility Name
Research centre Barcelona, ES003
City
Barcelona
Country
Spain
Facility Name
Research centre Vigo, ES004
City
Vigo
Country
Spain
Facility Name
Research centre Bern, CH006
City
Bern
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
30719976
Citation
Cassese S, Katagiri Y, Byrne RA, Brugaletta S, Alfonso F, Raber L, Maeng M, Iniguez A, Kretov E, Onuma Y, Joner M, Sabate M, Laugwitz KL, Windecker S, Kastrati A, Serruys PW. Angiographic and clinical outcomes of STEMI patients treated with bioresorbable or metallic everolimus-eluting stents: a pooled analysis of individual patient data. EuroIntervention. 2020 Mar 20;15(16):1451-1457. doi: 10.4244/EIJ-D-18-01080.
Results Reference
derived
PubMed Identifier
28935079
Citation
Yamaji K, Brugaletta S, Sabate M, Iniguez A, Jensen LO, Cequier A, Hofma SH, Christiansen EH, Suttorp M, van Es GA, Sotomi Y, Onuma Y, Serruys PW, Windecker S, Raber L. Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: An Angiographic and Optical Coherence Tomography TROFI II Substudy. JACC Cardiovasc Interv. 2017 Sep 25;10(18):1867-1877. doi: 10.1016/j.jcin.2017.07.035.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/26405232
Description
Primary endpoint manuscript (PUBMED ID: 26405232)
Learn more about this trial
ABSORB STEMI: the TROFI II Study
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