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

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ClinicalTrials.gov Identifier: NCT02464397
Recruitment Status : Unknown
Verified June 2015 by Pasi Karjalainen, The Hospital District of Satakunta.
Recruitment status was:  Recruiting
First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Pasi Karjalainen, The Hospital District of Satakunta

Brief 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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: Stent Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tryptophan

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.
Device: Stent
In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
Other Name: PCI

Active Comparator: SYNERGY-EES 1
SYNERGY™ everolimus eluting stent (EES). Patients will have OCT follow-up 1 month after the index procedure.
Device: Stent
In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
Other Name: 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.
Device: Stent
In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
Other Name: PCI

Active Comparator: SYNERGY-EES 6
SYNERGY™ everolimus eluting stent (EES). Patients will have OCT follow-up 6 months after the index procedure.
Device: Stent
In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
Other Name: PCI




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464397


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

Locations
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Belgium
Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium Recruiting
Aalst, Belgium
Contact: Bernard de Bruyne, MD         
Principal Investigator: Bernard de Bruyne, MD         
Finland
Heart Center, Satakunta Central Hospital Recruiting
Pori, Finland, 28500
Contact: Pasi Karjalainen, MD, PhD    +358 2 627 7500    pasi.karjalainen@satshp.fi   
Principal Investigator: Pasi Karjalainen, MD, Phd         
Sub-Investigator: Jussi Mikkelsson, MD,PhD         
Sub-Investigator: Tuomas Paana, MD         
Sponsors and Collaborators
The Hospital District of Satakunta
Investigators
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Study Director: Pasi P Karjalainen, MD, phd Heart Center, Satakunta Central Hospital

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Responsible Party: Pasi Karjalainen, Professor, The Hospital District of Satakunta
ClinicalTrials.gov Identifier: NCT02464397     History of Changes
Other Study ID Numbers: SA-010
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by Pasi Karjalainen, The Hospital District of Satakunta:
Vascular healing of coronary stents in patients with acute coronary syndrome
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Everolimus
Tryptophan
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs