- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464397
Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents (OPTIMAX-OCT)
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
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Pasi P Karjalainen, MD, PhD
- Phone Number: +358 2 627 7500
- Email: pasi.karjalainen@satshp.fi
Study Locations
-
-
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Aalst, Belgium
- Recruiting
- Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium
-
Contact:
- Bernard de Bruyne, MD
-
Principal Investigator:
- Bernard de Bruyne, MD
-
-
-
-
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Pori, Finland, 28500
- Recruiting
- Heart Center, Satakunta Central Hospital
-
Contact:
- Pasi Karjalainen, MD, PhD
- Phone Number: +358 2 627 7500
- Email: pasi.karjalainen@satshp.fi
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Principal Investigator:
- Pasi Karjalainen, MD, Phd
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Sub-Investigator:
- Jussi Mikkelsson, MD,PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
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:
|
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:
|
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:
|
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:
|
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
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In Study A, time for the OCT primary endpoint is 1month
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1 month
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Primary endpoint is the percentage of stent struts coverage per group
Time Frame: 6 months
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In Study B, time for the OCT primary endpoint is 6 month
|
6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of stent strut malapposition
Time Frame: 1 and 6 months
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1 and 6 months
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Maximum length of segment (mm) with uncovered stent struts
Time Frame: 1 and 6 months
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1 and 6 months
|
Maximum length of segment (mm) with malapposed stent struts
Time Frame: 1 and 6 months
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1 and 6 months
|
Maximum malapposition distance
Time Frame: 1 and 6 months
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1 and 6 months
|
Total malapposition volume
Time Frame: 1 and 6 months
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1 and 6 months
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Mean neointimal thickness
Time Frame: 1 and 6 months
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1 and 6 months
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Percentage of protruding struts per stent
Time Frame: 1 and 6 months
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1 and 6 months
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Stent area
Time Frame: 1 and 6 months
|
1 and 6 months
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NIH volume
Time Frame: 1 and 6 months
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1 and 6 months
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Thrombus formation
Time Frame: 1 and 6 months
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1 and 6 months
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In-stent late loss
Time Frame: 6 months
|
6 months
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In-segment late loss
Time Frame: 6 months
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6 months
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In-stent binary restenosis
Time Frame: 6 months
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6 months
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In-segment binary restenosis
Time Frame: 6 months
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6 months
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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
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1, 6, and 12 months
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Target vessel revascularization
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
Investigators
- Study Director: Pasi P Karjalainen, MD, phd, Heart Center, Satakunta Central Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SA-010
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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