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Acute ST Segment Elevation Myocardial InfarctionNCT01986803

ABSORB STEMI: the TROFI II Study

A study testing Percutaneous Coronary Intervention in people with Acute ST Segment Elevation Myocardial Infarction, run by ECRI bv at 8 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Percutaneous Coronary Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
8 sitesin 4 countries
Study dates
6 Jan 2014to 21 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

Spain3 sites

  • Research centre Barcelona, ES001

    Barcelona

  • Research centre Barcelona, ES003

    Barcelona

  • Research centre Vigo, ES004

    Vigo

Other trials in Spain

Denmark2 sites

  • Research centre Aarhus, DK003

    Aarhus

  • Research centre Odense, DK002

    Odense

Other trials in Denmark

Netherlands2 sites

  • Research centre Leeuwarden, NL002

    Leeuwarden

  • Research centre Nieuwegein, NL014

    Nieuwegein

Other trials in Netherlands

Switzerland1 site

  • Research centre Bern, CH006

    Bern

Other trials in Switzerland

About this 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

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.

Read more

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.

Read the 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.

Being tested
Percutaneous Coronary Intervention
Keywords
ST-elevation Myocardial Infarction (STEMI), Primary Percutaneous Coronary Intervention within 24 hrs, Healing score, OFDI
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary InterventionDevice

    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.

Study groups in NCT01986803
Study groupRoleWhat they receive
PCI with ABSORBTM bioresorbable vascular scaffold system (BVS)ExperimentalAll 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)
Receives: Device: Percutaneous Coronary Intervention
PCI with XIENCE Xpedition stentActive comparatorAll 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)
Receives: Device: Percutaneous Coronary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    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".

    Measured: 6 months follow-up

Secondary outcomes (40)

  1. 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.

    Measured: Study patients will be followed for the duration of hospital stay (e.g. until hospital discharge), an expected average of 2 days.

  2. 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.

    Measured: Up to 3 years

  3. Cardiac Death

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

    Measured: Up to 6 months

  4. Cardiac Death

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

    Measured: Up to 3 years

  5. 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.

    Measured: Up to 6 months

  6. 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.

    Measured: Up to 3 years

  7. 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.

    Measured: Up to 6 months

  8. 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.

    Measured: Up to 3 years

  9. All-cause death at all timepoints

    Clinical Endpoint.

    Measured: Up to 6 months

  10. All-cause death at all timepoints

    Clinical Endpoint.

    Measured: Up to 3 years

  11. Any Myocardial Infarction at all timepoints

    Clinical Endpoint.

    Measured: Up to 6 months

  12. Any Myocardial Infarction at all timepoints

    Clinical Endpoint.

    Measured: Up to 3 years

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

    Clinical Endpoint.

    Measured: Up to 6 months

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

    Clinical Endpoint.

    Measured: Up to 3 years

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

    Clinical Endpoint.

    Measured: Up to 6 months

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

    Clinical Endpoint.

    Measured: Up to 3 years

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

    Clinical Endpoint. ARC = academic research consortium

    Measured: Up to 6 months

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

    Clinical Endpoint. ARC = academic research consortium

    Measured: Up to 3 years

  19. Angina Class at all timepoints

    Clinical Endpoint. Angina Pectoris

    Measured: Up to 6 months

  20. Angina Class at all timepoints

    Clinical Endpoint. Angina Pectoris

    Measured: Up to 3 years

  21. Other Serious Adverse Events at all timepoints

    Clinical Endpoint.

    Measured: Up to 6 months

  22. Other Serious Adverse Events at all timepoints

    Clinical Endpoint.

    Measured: Up to 3 years

  23. 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.

    Measured: Up to 6 months

  24. Percent diameter stenosis (%DS)

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

    Measured: Up to 6-months

  25. Minimal Lumen Diameter(MLD)

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

    Measured: Up to 6-months

  26. 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

    Measured: Up to 6-months

  27. Angiographic binary restenosis (ABR)

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

    Measured: Up to 6-months

  28. Presence of filling defect (%ILD)

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

    Measured: 6-months

  29. 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".

    Measured: 6-months

  30. 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".

    Measured: 6-months

  31. 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".

    Measured: 6-months

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

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

    Measured: 6-months

  33. Mean/minimal lumen diameter/area/volume

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

    Measured: 6-months

  34. Incomplete strut apposition (ISA) area/volume

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

    Measured: 6-months

  35. Percentage of covered struts

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

    Measured: 6-months

  36. Mean/maximal thickness of the struts coverage

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

    Measured: 6-months

  37. Neointimal hyperplasia area/volume

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

    Measured: 6-months

  38. Mean Flow area/volume

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

    Measured: 6-months

  39. Intraluminal defect area/volume

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

    Measured: 6-months

  40. 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.

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2013 (estimated)
  2. Study start6 Jan 2014
  3. Primary completion13 Apr 2015
  4. Study completion21 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01986803
Sponsor's protocol ID
ECRI-003
Status last verified
Jul 2018
First submitted
29 Aug 2013
Last updated
24 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30719976

  • 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.

    PubMed 28935079

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Coronary Intervention in people with Acute ST Segment Elevation Myocardial Infarction, run by ECRI bv at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain, Denmark, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healing Score (time frame: 6 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01986803, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.

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