Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT02464397
• Date of registration: 01/06/2015
• Prospective Registration: No
• Primary sponsor: The Hospital District of Satakunta
• Public title: Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents OPTIMAX-OCT
• Scientific 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
• Date of first enrolment: February 2015
• Target sample size: 110
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02464397
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Belgium, Finland

Contacts

• Name: Pasi P Karjalainen, MD, PhD

• Name: Pasi P Karjalainen, MD, phd
• Affiliation: Heart Center, Satakunta Central Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Coronary Syndrome

Intervention(s)

Device: Stent

Primary Outcome(s)

Primary endpoint is the percentage of stent struts coverage per group [Time Frame: 6 months]

Primary endpoint is the percentage of stent struts coverage per group [Time Frame: 1 month]

Secondary Outcome(s)

In-segment late loss [Time Frame: 6 months]

Percentage of protruding struts per stent [Time Frame: 1 and 6 months]

In-stent late loss [Time Frame: 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]

NIH volume [Time Frame: 1 and 6 months]

Percentage of stent strut malapposition [Time Frame: 1 and 6 months]

In-segment binary restenosis [Time Frame: 6 months]

In-stent binary restenosis [Time Frame: 6 months]

Maximum length of segment (mm) with malapposed stent struts [Time Frame: 1 and 6 months]

Maximum malapposition distance [Time Frame: 1 and 6 months]

Mean neointimal thickness [Time Frame: 1 and 6 months]

Target vessel revascularization [Time Frame: 6 months]

Maximum length of segment (mm) with uncovered stent struts [Time Frame: 1 and 6 months]

Stent area [Time Frame: 1 and 6 months]

Thrombus formation [Time Frame: 1 and 6 months]

Total malapposition volume [Time Frame: 1 and 6 months]

Secondary ID(s)

SA-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors