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Status unknownNCT02464397OPTIMAX-OCTUpdated Jun 8, 2015

Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents

A Phase 4 interventional study of Stent in Acute Coronary Syndrome, sponsored by The Hospital District of Satakunta. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-08.

Sponsored by The Hospital District of Satakunta · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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
02

Conditions studied

  • Acute Coronary Syndrome

Keywords

  • Vascular healing of coronary stents in patients with acute coronary syndrome
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's planned enrollment of 110 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

The Hospital District of Satakunta is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age >18 and \<80 years
  2. 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)
  3. Patient is willing to comply with specified follow-up evaluations
  4. 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.
  5. Single de novo or non-stented restenosis lesion
  6. 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.
  7. Target lesion (maximum 20 mm length by visual estimation) to be covered by a single stent of maximum 23mm length.
  8. Reference vessel diameter must be >2.5mm and \<4.0mm by visual estimate.
  9. The vessel diameter should be measured after pre-dilation procedure and after intracoronary nitroglycerin if vasospasm is suspected.
  10. Target lesion >50% and \<100% stenosed by visual estimate.

Exclusion criteria

Exclusion Criteria:

  1. Impaired renal function (serum creatinine >177micromol/l) or on dialysis
  2. Platelet count \< 10 e5 cells/mm3
  3. Patient has a history of bleeding diathesis or coagulopathy or patients in whom antiplatelet and and/or anticoagulation therapy is contraindicated.
  4. Patient has received organ transplant or is on a waiting list for any organ transplant.
  5. 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.
  6. Patient presents with cardiogenic shock.
  7. Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study.
  8. Currently participating in another investigational drug or device study.
  9. Unprotected left main disease.
  10. Ostial target lesions.
  11. Chronic total occlusion.
  12. Calcified target lesions that cannot be adequately pre-dilated.
  13. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment.
  14. Target lesion involving bifurcation with a side branch larger than 2.0mm in diameter.
  15. A >30% stenosis proximal or distal to the target lesion that cannot be covered with the same stent.
  16. Diffuse distal disease.
  17. Prior stent in the target vessel.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    OPTIMAX-BAS 1

    Titanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS). Patients will have OCT follow-up 1 month after the index procedure.

    Device: Stent

  • Active comparator
    SYNERGY-EES 1

    SYNERGY™ everolimus eluting stent (EES). Patients will have OCT follow-up 1 month after the index procedure.

    Device: Stent

  • Experimental
    OPTIMAX-OCT 6

    Titanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS). Patients will have OCT follow-up 6 months after the index procedure.

    Device: Stent

  • Active comparator
    SYNERGY-EES 6

    SYNERGY™ everolimus eluting stent (EES). Patients will have OCT follow-up 6 months after the index procedure.

    Device: Stent

Interventions

  • DeviceStent

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

    Also known as: PCI

06

What researchers measure

Primary outcomes

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

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

    Time frame: 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

    Time frame: 6 months

Secondary outcomes

  1. Percentage of stent strut malapposition

    Time frame: 1 and 6 months

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

    Time frame: 1 and 6 months

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

    Time frame: 1 and 6 months

  4. Maximum malapposition distance

    Time frame: 1 and 6 months

  5. Total malapposition volume

    Time frame: 1 and 6 months

  6. Mean neointimal thickness

    Time frame: 1 and 6 months

  7. Percentage of protruding struts per stent

    Time frame: 1 and 6 months

  8. Stent area

    Time frame: 1 and 6 months

  9. NIH volume

    Time frame: 1 and 6 months

  10. Thrombus formation

    Time frame: 1 and 6 months

  11. In-stent late loss

    Time frame: 6 months

  12. In-segment late loss

    Time frame: 6 months

  13. In-stent binary restenosis

    Time frame: 6 months

  14. In-segment binary restenosis

    Time frame: 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)

    Time frame: 1, 6, and 12 months

  16. Target vessel revascularization

    Time frame: 6 months

07

Study locations

2 of 2 sites recruiting
  • Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium
    Aalst, Belgium
    • Bernard de Bruyne, MD · Contact
    • Bernard de Bruyne, MD · Principal investigator
    Recruiting
  • Heart Center, Satakunta Central Hospital
    Pori, 28500, Finland
    • Pasi Karjalainen, MD, PhD · Contact · pasi.karjalainen@satshp.fi · +358 2 627 7500
    • Pasi Karjalainen, MD, Phd · Principal investigator
    • Jussi Mikkelsson, MD,PhD · Sub investigator
    • Tuomas Paana, MD · Sub investigator
    Recruiting
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02464397
Lead sponsor
The Hospital District of Satakunta
Responsible party
Pasi Karjalainen (Professor, The Hospital District of Satakunta) — Principal investigator
First posted
Jun 8, 2015
Start date
Feb 2015
Primary completion
Aug 2016 (estimated)
Completion
Aug 2017 (estimated)
Last update
Jun 8, 2015

Study contacts

Pasi P Karjalainen, MD, PhD
Contact
pasi.karjalainen@satshp.fi
+358 2 627 7500
Pasi P Karjalainen, MD, phd
study director · Heart Center, Satakunta Central Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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