Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents

NCT02464397 | Unknown Phase 4

• 1 other identifier: SA-010
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 2

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.

Conditions

Acute Coronary Syndrome

Keywords

Vascular healing of coronary stents in patients with acute coronary syndrome

Outcome Measures

Primary Outcomes (2)

• Primary endpoint is the percentage of stent struts coverage per group

  In Study A, time for the OCT primary endpoint is 1month

  1 month

• 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

Secondary Outcomes (16)

• Percentage of stent strut malapposition

  1 and 6 months

• Maximum length of segment (mm) with uncovered stent struts

  1 and 6 months

• Maximum length of segment (mm) with malapposed stent struts

  1 and 6 months

• Maximum malapposition distance

  1 and 6 months

• Total malapposition volume

  1 and 6 months

Study Arms (4)

OPTIMAX-BAS 1

EXPERIMENTAL

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

SYNERGY-EES 1

ACTIVE COMPARATOR

SYNERGY™ everolimus eluting stent (EES). Patients will have OCT follow-up 1 month after the index procedure.

Device: Stent

OPTIMAX-OCT 6

EXPERIMENTAL

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

SYNERGY-EES 6

ACTIVE COMPARATOR

SYNERGY™ everolimus eluting stent (EES). Patients will have OCT follow-up 6 months after the index procedure.

Device: Stent

Interventions

Stent DEVICE

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

Also known as: PCI

OPTIMAX-BAS 1; OPTIMAX-OCT 6; SYNERGY-EES 1; SYNERGY-EES 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital District of Satakunta: lead

Study Sites (2)

Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium

Aalst, Belgium

RECRUITING

Heart Center, Satakunta Central Hospital

Pori, 28500, Finland

RECRUITING

Related Publications (1)

• Sia J, Nammas W, Collet C, De Bruyne B, Karjalainen PP. Comparative study of neointimal coverage between titanium-nitric oxide-coated and everolimus-eluting stents in acute coronary syndromes. Rev Esp Cardiol (Engl Ed). 2023 Mar;76(3):150-156. doi: 10.1016/j.rec.2022.05.017. Epub 2022 Jun 2. English, Spanish.

  PMID: 35752571 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Stents

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Pasi P Karjalainen, MD, phd

  Heart Center, Satakunta Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Pasi P Karjalainen, MD, PhD

CONTACT

+358 2 627 7500; pasi.karjalainen@satshp.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 8, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

FI (1); BE (1)