Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents

Acute Coronary Syndrome Clinical Trial

— OPTIMAX-OCT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02464397
• Other study ID #: SA-010
• Status: Recruiting
• Phase: Phase 4
• First received: June 1, 2015
• Last updated: June 3, 2015
• Start date: February 2015
• Est. completion date: August 2017

Study information

• Verified date: June 2015
• Source: The Hospital District of Satakunta
• Contact: Pasi P Karjalainen, MD, PhD
• Phone: +358 2 627 7500
• Email: pasi.karjalainen[@]satshp.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

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

Locations

Country	Name	City	State
Belgium	Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium	Aalst
Finland	Heart Center, Satakunta Central Hospital	Pori

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital District of Satakunta

Countries where clinical trial is conducted

Belgium,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint is the percentage of stent struts coverage per group	In Study A, time for the OCT primary endpoint is 1month	1 month	Yes
Primary	Primary endpoint is the percentage of stent struts coverage per group	In Study B, time for the OCT primary endpoint is 6 month	6 months	Yes
Secondary	Percentage of stent strut malapposition		1 and 6 months	Yes
Secondary	Maximum length of segment (mm) with uncovered stent struts		1 and 6 months	No
Secondary	Maximum length of segment (mm) with malapposed stent struts		1 and 6 months	No
Secondary	Maximum malapposition distance		1 and 6 months	No
Secondary	Total malapposition volume		1 and 6 months	No
Secondary	Mean neointimal thickness		1 and 6 months	No
Secondary	Percentage of protruding struts per stent		1 and 6 months	No
Secondary	Stent area		1 and 6 months	No
Secondary	NIH volume		1 and 6 months	No
Secondary	Thrombus formation		1 and 6 months	Yes
Secondary	In-stent late loss		6 months	No
Secondary	In-segment late loss		6 months	No
Secondary	In-stent binary restenosis		6 months	No
Secondary	In-segment binary restenosis		6 months	No
Secondary	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)		1, 6, and 12 months	Yes
Secondary	Target vessel revascularization		6 months	No