AzTrials
AzTrials

Acute ST Segment Elevation Myocardial InfarctionPhase 3BVS in STEMINCT02067091

Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct

A Phase 3 study testing stent implant in a coronary artery in people with Acute ST Segment Elevation Myocardial Infarction, run by Haukeland University Hospital at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Patients presenting with acute ST elevation myocardial infarct urgently need revascularization. Standard of care is establishing bloodflow through the coronary vessels using thrombus aspiration catheter, and securing the result by using a metallic drug eluting stent. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
stent implant in a coronary artery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesin 2 countries
Study dates
Aug 2014to Aug 2020
Phase
Phase 3
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

  • History of chest pain < 12 hrs
  • ST elevation of ≥ 2 mm in ≥2 contiguous precordial leads (V1-V6), and/or ≥ 1 mm in ≥ 2 contiguous standard leads (I, II, III, aVf, aVr,aVl).
  • Clinical decision to treat with primary PCI
  • > 18 years
  • Oral informed consent

Who cannot join

  • Contraindications to long term double antiplatelet therapy
  • Known kidney failure with GFR < 45
  • Cardiac arrest or severe cardiogenic shock (Persistent BP <90 mmHg, despite adequate treatment)
  • Other severe illness with life expectancy of less than 12 months (eg. malignancy, severe malnutrition, degenerative disease)
  • Procedural contraindications:
  • Heavy calcification, tortuous vessel or large side branch (> 2,5 mm) at culprit lesion.
  • TIMI 0-1 flow after aspiration
  • Unable to advance thrombus aspiration catheter

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Denmark1 site

  • Aarhus University Hospital, Skejby

    Aarhus

Other trials in Denmark

Norway1 site

  • Haukeland University Hospital

    Bergen, 5021

Other trials in Norway

About this study

Official title: Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI)

Patients presenting with acute ST elevation myocardial infarct urgently need revascularization. Standard of care is establishing bloodflow through the coronary vessels using thrombus aspiration catheter, and securing the result by using a metallic drug eluting stent. New kinds of non-metallic bioresorbable stents are now available. They have however challenges in structural strength.

The investigators want to compare the new bioresorbable scaffold with traditional metallic stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120 patients. The investigators will use an imaging technique, optical coherence tomography, to evaluate the results after 12 months.

The investigators also want to see if modern multislice computed tomography can give useful information in the follow-up of stented coronary arteries after 12 and 24 months.

Read the detailed description

Patients presenting with ST elevation myocardial infarction for primary PCI (percutaneous coronary intervention) will be screened. After thrombus aspiration, patient will be asked for oral consent if TIMI flow 2-3. Patient will then be randomized between drug eluting stent (Xience pro, Abbott Vascular Solutions) and bioresorbable scaffold (Absorb, Abbott Vascular Solutions). Optical coherence tomography (OCT) will be performed before stenting and after final result. Stent will be deployed without further predilatation if possible. Follow up at 12 months (clinical, angio with OCT and multislice CT coronary angiogram (MSCT-CA)) and 24 months (MSCT-CA).

Being tested
stent implant in a coronary artery
Keywords
STEMI, Coronary, Bioresorbable scaffold, Drug eluting stent, Optical coherence tomography, Multislice computed tomography
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.

  • stent implant in a coronary arteryDevice

    Implantation of device called a stent in a coronary artery

    Percutaneous coronary intervention

Study groups in NCT02067091
Study groupRoleWhat they receive
BVSActive comparatorImplantation of bioresorbable vascular scaffold in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention
Receives: Device: stent implant in a coronary artery
DESActive comparatorImplantation of drug eluting stent in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention
Receives: Device: stent implant in a coronary artery

What is being measured

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

  1. Coronary Stent Healing Index (cumulated)

    1. Uncovered struts: 2% =1 - 5% =2 - 10% =3 - 15% =4 - 20% =5 - 25% =6 - 30% =7 - 35% =8 - 40% =9
    2. Uncovered struts in front of side branch on acquired or persistent malposed struts. 10% =1 - 20% =2 - 30% =3 etc… til 100%=10
    3. Persistent malposition: ≥2 nabo struts længde mindst 1 mm =1 ; ≥2mm=3 ; ≥3 mm = 3
    4. Acquired malposition: ≥2 adjacent struts of at least 1 mm length =2 ; ≥2mm=4 ; ≥3 mm = 6
    5. Neointimal thickness in one frame >200 =1 - >300 =2 - >400 =3 or diameter stenosis >50% =4 - > 75% =5
    6. Cumulated extra stent lumen increase in match cross sectional analysis: (gns. areal mål): ≥0.2mm2 =1 ; ≥0.4 mm2 = 2; ≥0.6mm2=3 ; ≥0.8 mm2 = 4 ; ≥1.0 mm2=5 ; ≥1.2 mm2 = 6

    Measured: 12 months

  2. Multislice computed tomography

    MSCT-CA will be done at 24 months to extend the observational time by a non-invasive measure. MSCT-CA will be compared to conventional angiogram with OCT at 12 months to verify MSCT-CA findings at 24 months. Results will be reported in separate paper.

    Measured: 24 months

  3. Minimum Flow Area

    Minimum flow area as defined in TROFI I, measured by OCT

    Measured: 12 months

Secondary outcomes (26)

  1. Total Death

    Total death encompasses cardiac death and other fatal categories, which include cerebrovascular death, death from other cardiovascular disease (i.e. pulmonary embolism, dissection aortic aneurysm will be included in this category), death from malignant disease, death from suicide, violence or accident, or death from other reasons.

    Measured: 5 years

  2. Cardiac death

    Cardiac death encompasses coronary heart disease death including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related to a cardiac procedure or surgery within 28 days from the procedure.

    Measured: 5 years

  3. Myocardial infarction

    Evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Under these conditions any one of the following criteria meets the diagnosis for myocardial infarction :

    1. Detection of rise and/or fall of preferably troponin T with at least one value above the 99th percentile of the upper reference limit (URL) together with evidence of myocardial ischemia with at least one of the following (MI types 1 or 2):
    2. Symptoms of ischemia
    3. ECG changes indicative of new ischemia (new ST-T changes or new LBBB)
    4. Development of pathological Q waves in the ECG
    5. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
    6. Sudden, unexpected cardiac death, involving cardiac arrest.

    Measured: 5 years

  4. Stent thrombosis

    Stent thrombosis is recognized when documented by angiography and/or autopsy and when meeting the criteria for spontaneous myocardial infarction occurring in the territory of the treated vessel (11). Stent thrombosis are categorized as acute, sub-acute, late and very late and as definite, probable and possible according to the ARC-criteria (12).

    Measured: 5 years

  5. Target Lesion and vessel Revascularization

    Coronary artery bypass grafting with grafting or PCI of index lesion. Coronary artery bypass grafting with grafting or PCI of index vessel.

    Measured: 5 years

  6. Non Target vessel revascularisation

    All PCI or coronary bypass grafting of non index vessel

    Measured: 5 years

  7. Stable angina

    Angina as reported by patient, classified according to Canadian cardiac society class (CCS)

    Measured: 5 years

  8. Vascular cerebral events

    Vascular events documented by neurological permanent disabilities or by diagnostic imaging (MRI or CT).

    Measured: 5 years

  9. Admission for congestive heart failure or arrhythmias

    Admissions were the diagnosis at release is one of heart failure or arrhythmias

    Measured: 5 years

  10. Optical Coherence tomography

    Area stenosis

    Measured: 12 months

  11. Angiographic endpoints at index admission

    TIMI flow pre and post PCI

    Measured: After index procedure were the patient is included and randomized

  12. Biochemical

    Creatinine, hemoglobin, Troponin T will be analyzed during index procedure post procedure and at 12 months follow-up. ProBNP will be analyzed at 12 months follow-up

    Measured: 12 months

  13. Markers

    Plasma, full blood, serum and urine will be drawn immediately after the procedure and frozen in a bio bank for later analysis

    Measured: 12 months

  14. Thrombus analysis

    Visible thrombus aspirates will be sent for analysis

    Measured: At index procedure were the patient is included and randomized

  15. Optical coherence tomography

    Lumen late loss

    Measured: 12 months

  16. Optical coherence tomography

    Crushed stent segments

    Measured: 12 months

  17. Optical coherence tomography

    Malposition of stent segments

    Measured: 12 months

  18. Optical coherence tomography

    Minimum expansion of stent struts expressed as absolute area and percentage of closest reference reference area

    Measured: 12 months

  19. Optical coherence tomography

    Vessel ostial stented area (acute and at FU)

    Measured: 12 months

  20. Optical coherence tomography

    Thrombus burden

    Measured: 12 months

  21. Angiographic endpoints at index admission

    Blush grade

    Measured: After index procedure were the patient is included and randomized

  22. Angiographic endpoints at index admission

    Thrombus burden

    Measured: After index procedure were the patient is included and randomized

  23. Angiographic endpoints at index admission

    Angiographic complications

    Measured: After index procedure were the patient is included and randomized

  24. Angiographic endpoints at index admission

    Contrast use

    Measured: After index procedure were the patient is included and randomized

  25. Angiographic endpoints at index admission

    Procedure time

    Measured: After index procedure were the patient is included and randomized

  26. Angiographic endpoints at index admission

    Radiation skin dose

    Measured: After index procedure were the patient is included and randomized

Timeline

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

  1. First posted20 Feb 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionApr 2018 (estimated)
  4. Study completionAug 2020 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02067091
Sponsor's protocol ID
2013/2006
Acronym
BVS in STEMI
Status last verified
May 2017
First submitted
11 Feb 2014
Last updated
31 May 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing stent implant in a coronary artery in people with Acute ST Segment Elevation Myocardial Infarction, run by Haukeland University Hospital at 2 sites in 2 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 8 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: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark, Norway. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Coronary Stent Healing Index (cumulated) (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT02067091.

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 31 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in