AzTrials
AzTrials

Acute Coronary SyndromePhase 4OPTIMAX-OCTNCT02464397

Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents

A Phase 4 study testing Stent in people with Acute Coronary Syndrome, run by The Hospital District of Satakunta 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS) and SYNERGY™ everolimus-eluting stent (EES) in patients with acute coronary syndromes requiring percutaneous coronary intervention. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
2 sitesin 2 countries
Study dates
Feb 2015to Aug 2017
Phase
Phase 4
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age >18 and <80 years
  • STEMI or NSTEMI (assumed by investigator to be type 1 myocardial infarction, according to universal definitions of MI; EHJ 2007; 28(20):2525-38); or unstable angina (clinical symptoms of chest pain, ecg suggestive of reversible ischemia)
  • Patient is willing to comply with specified follow-up evaluations
  • Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics committee or Institutional Review Board.
  • Single de novo or non-stented restenosis lesion
  • Patients with two-vessel disease may have undergone successful treatment of the non-target vessel with approved devices up to and including the index procedure but must be prior to the index target vessel treatment.
Show all 10Show fewer
  • Target lesion (maximum 20 mm length by visual estimation) to be covered by a single stent of maximum 23mm length.
  • Reference vessel diameter must be >2.5mm and <4.0mm by visual estimate.
  • The vessel diameter should be measured after pre-dilation procedure and after intracoronary nitroglycerin if vasospasm is suspected.
  • Target lesion >50% and <100% stenosed by visual estimate.

Who cannot join

  • Impaired renal function (serum creatinine >177micromol/l) or on dialysis
  • Platelet count < 10 e5 cells/mm3
  • Patient has a history of bleeding diathesis or coagulopathy or patients in whom antiplatelet and and/or anticoagulation therapy is contraindicated.
  • Patient has received organ transplant or is on a waiting list for any organ transplant.
  • Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/prasugrel/ticagrelol, cobalt chromium alloy, or contrast agent that cannot be adequately pre-medicated.
  • Patient presents with cardiogenic shock.
Show all 17Show fewer
  • Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study.
  • Currently participating in another investigational drug or device study.
  • Unprotected left main disease.
  • Ostial target lesions.
  • Chronic total occlusion.
  • Calcified target lesions that cannot be adequately pre-dilated.
  • Target lesion has excessive tortuosity unsuitable for stent delivery and deployment.
  • Target lesion involving bifurcation with a side branch larger than 2.0mm in diameter.
  • A >30% stenosis proximal or distal to the target lesion that cannot be covered with the same stent.
  • Diffuse distal disease.
  • Prior stent in the target vessel.

Trial locations and contacts

2 sites in 2 countries.

Pasi P Karjalainen, MD, PhD contact

+358 2 627 7500

pasi.karjalainen@satshp.fi

2 sites in 2 countries

Belgium1 site, 1 recruiting

  • Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium

    Aalst

    Bernard de Bruyne, MD

    Bernard de Bruyne, MD

    Recruiting

Other trials in Belgium

Finland1 site, 1 recruiting

  • Heart Center, Satakunta Central Hospital

    Pori, 28500

    Pasi Karjalainen, MD, PhD, +358 2 627 7500, pasi.karjalainen@satshp.fi

    Pasi Karjalainen, MD, Phd

    Recruiting

Other trials in Finland

About this study

Official title: A Randomized Prospective Multicenter Trial to Examine Vascular Healing at 1 and 6 Month(s) After Deployment of TItanium-nitride-oxide-coated OPTIMAX™ Bio-active-stent (BAS) Stent and SYNERGY™ Everolimus-Eluting Stent (EES) in Patients With Acute Coronary Syndromes by Means of Optical Coherence Tomography

The purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS) and SYNERGY™ everolimus-eluting stent (EES) in patients with acute coronary syndromes requiring percutaneous coronary intervention.

Patients treated with BAS will be treated with DAPT for at least 4 weeks after the procedure followed by aspirin alone, while patients in the EES group will be treated with DAPT, at least for 6 months post procedure. In addition, this study will collect initial information about the safety and effectiveness of the BAS in comparison with EES group at 30 days, 6 months, and 12 months.

Read the detailed description

OPTIMAX-OCT is a prospective, randomized (1:1), study that will be conducted at 2-3 sites (Finland, Belgium) to evaluate OPTIMAX-BAS vascular healing patterns and thrombus formation with OCT at one (Study A) and six (Study B) month after stent implantation in comparison with SYNERGY-EES. Patients receiving BAS will receive dual antiplatelet treatment (DAPT) for at least four weeks followed by aspirin, while patients implanted with EES, will receive DAPT for at least 6 months followed by aspirin.

Patients will be randomized to study A and B as follow:

Study A: OPTIMAX-BAS (n=25) versus SYNERGY-EES (n=25). First 50 patients will be randomized to study A. OCT at 1 month follow up.

Study B: OPTIMAX-BAS (n=30) versus SYNERGY-EES (n=30) Following 60 patients will be randomized to study B. OCT at 6 months follow up.

Randomization is used at the time of recruitment with sealed envelopes. Patients will be randomized in 1:1 fashion. First 50 patients are randomized in study A and following 60 patients in study B. Patients in study A will have OCT follow up at 1 month after index procedure and patients in study B will have OCT at 6 months.

OCT analyses will be performed blinded to patient's characteristics as well as the type of the stent used.

Two (2-3) investigational sites:

  • Cardiovascular Center Aalst, Aalst, Belgium
  • Heart Center, Satakunta Central Hospital, Pori, Finland
Being tested
Stent
Keywords
Vascular healing of coronary stents in patients with acute coronary syndrome
Medical subject headings
Acute Coronary Syndrome

What participants receive

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

  • StentDevice

    Also called PCI

    In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion

Study groups in NCT02464397
Study groupRoleWhat they receive
OPTIMAX-BAS 1ExperimentalTitanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS). Patients will have OCT follow-up 1 month after the index procedure.
Receives: Device: Stent
SYNERGY-EES 1Active comparatorSYNERGY™ everolimus eluting stent (EES). Patients will have OCT follow-up 1 month after the index procedure.
Receives: Device: Stent
OPTIMAX-OCT 6ExperimentalTitanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS). Patients will have OCT follow-up 6 months after the index procedure.
Receives: Device: Stent
SYNERGY-EES 6Active comparatorSYNERGY™ everolimus eluting stent (EES). Patients will have OCT follow-up 6 months after the index procedure.
Receives: Device: Stent

What is being measured

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

  1. Primary endpoint is the percentage of stent struts coverage per group

    In Study A, time for the OCT primary endpoint is 1month

    Measured: 1 month

  2. Primary endpoint is the percentage of stent struts coverage per group

    In Study B, time for the OCT primary endpoint is 6 month

    Measured: 6 months

Secondary outcomes (16)

  1. Percentage of stent strut malapposition

    Measured: 1 and 6 months

  2. Maximum length of segment (mm) with uncovered stent struts

    Measured: 1 and 6 months

  3. Maximum length of segment (mm) with malapposed stent struts

    Measured: 1 and 6 months

  4. Maximum malapposition distance

    Measured: 1 and 6 months

  5. Total malapposition volume

    Measured: 1 and 6 months

  6. Mean neointimal thickness

    Measured: 1 and 6 months

  7. Percentage of protruding struts per stent

    Measured: 1 and 6 months

  8. Stent area

    Measured: 1 and 6 months

  9. NIH volume

    Measured: 1 and 6 months

  10. Thrombus formation

    Measured: 1 and 6 months

  11. In-stent late loss

    Measured: 6 months

  12. In-segment late loss

    Measured: 6 months

  13. In-stent binary restenosis

    Measured: 6 months

  14. In-segment binary restenosis

    Measured: 6 months

  15. Major adverse cardiac events defined as a composite of death, MI (Q wave or non-Q wave), emergent coronary artery bypass surgery (CABG), or justified target lesion revascularization (TLR)

    Measured: 1, 6, and 12 months

  16. Target vessel revascularization

    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 posted8 Jun 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionAug 2016 (estimated)
  4. Study completionAug 2017 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02464397
Sponsor's protocol ID
SA-010
Acronym
OPTIMAX-OCT
Status last verified
Jun 2015
First submitted
1 Jun 2015
Last updated
8 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Sia J, Nammas W, Collet C, De Bruyne B, Karjalainen PP. Comparative study of neointimal coverage between titanium-nitric oxide-coated and everolimus-eluting stents in acute coronary syndromes. Rev Esp Cardiol (Engl Ed). 2023 Mar;76(3):150-156. doi: 10.1016/j.rec.2022.05.017. Epub 2022 Jun 2. English, Spanish.

    PubMed 35752571

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Stent in people with Acute Coronary Syndrome, run by The Hospital District of Satakunta 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 10 inclusion and 17 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 8 Jun 2015. 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 Belgium, Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Contact Pasi P Karjalainen, MD, PhD (+358 2 627 7500, pasi.karjalainen@satshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary endpoint is the percentage of stent struts coverage per group (time frame: 1 month). The study lists 2 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 NCT02464397, which also lists 1 linked publication.

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 8 Jun 2015.

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