Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents (OPTIMAX-OCT)

June 3, 2015 updated by: Pasi Karjalainen, The Hospital District of Satakunta

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.

Study Overview

Status

Unknown

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Aalst, Belgium
        • Recruiting
        • Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium
        • Contact:
          • Bernard de Bruyne, MD
        • Principal Investigator:
          • Bernard de Bruyne, MD
      • Pori, Finland, 28500
        • Recruiting
        • Heart Center, Satakunta Central Hospital
        • Contact:
        • Principal Investigator:
          • Pasi Karjalainen, MD, Phd
        • Sub-Investigator:
          • Jussi Mikkelsson, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
Other Names:
  • PCI
ACTIVE_COMPARATOR: SYNERGY-EES 1
SYNERGY™ everolimus eluting stent (EES). Patients will have OCT follow-up 1 month after the index procedure.
In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
Other Names:
  • PCI
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.
In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
Other Names:
  • PCI
ACTIVE_COMPARATOR: SYNERGY-EES 6
SYNERGY™ everolimus eluting stent (EES). Patients will have OCT follow-up 6 months after the index procedure.
In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
Other Names:
  • PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint is the percentage of stent struts coverage per group
Time Frame: 1 month
In Study A, time for the OCT primary endpoint is 1month
1 month
Primary endpoint is the percentage of stent struts coverage per group
Time Frame: 6 months
In Study B, time for the OCT primary endpoint is 6 month
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of stent strut malapposition
Time Frame: 1 and 6 months
1 and 6 months
Maximum length of segment (mm) with uncovered stent struts
Time Frame: 1 and 6 months
1 and 6 months
Maximum length of segment (mm) with malapposed stent struts
Time Frame: 1 and 6 months
1 and 6 months
Maximum malapposition distance
Time Frame: 1 and 6 months
1 and 6 months
Total malapposition volume
Time Frame: 1 and 6 months
1 and 6 months
Mean neointimal thickness
Time Frame: 1 and 6 months
1 and 6 months
Percentage of protruding struts per stent
Time Frame: 1 and 6 months
1 and 6 months
Stent area
Time Frame: 1 and 6 months
1 and 6 months
NIH volume
Time Frame: 1 and 6 months
1 and 6 months
Thrombus formation
Time Frame: 1 and 6 months
1 and 6 months
In-stent late loss
Time Frame: 6 months
6 months
In-segment late loss
Time Frame: 6 months
6 months
In-stent binary restenosis
Time Frame: 6 months
6 months
In-segment binary restenosis
Time Frame: 6 months
6 months
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
1, 6, and 12 months
Target vessel revascularization
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Pasi P Karjalainen, MD, phd, Heart Center, Satakunta Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

August 1, 2017

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (ESTIMATE)

June 8, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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