Vascular Healing After Deployment of Titanium-nitride-oxide-coated OPTIMAX™ Stent and PROMUS-ELEMENT™ Everolimus-Eluting Stent

NCT02280720 | Completed Phase 4 DMC

• 1 other identifier: SA-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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™-stent stent and Promus-Element™ everolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.

1. 1.Comparison of OCT and CFR findings of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent and Promus-Element™ everolimus-eluting stent at two months after the index procedure.
2. 2.Comparison of intravascular coronary flow reserve measurement to non-invasive transthoracic echocardiography-derived coronary flow reserve measurement.
3. 3.Comparison of epicardial vasodilation to coronary microcirculatory vasodilation

Conditions

Acute Coronary Syndrome

Keywords

titanium-nitride-oxide-coated stent; everolimus-eluting stent; optical coherence tomography; strut coverage

Outcome Measures

Primary Outcomes (1)

• Percentage of uncovered struts

  2 months

Secondary Outcomes (1)

• Coronary flow reserve

  2 months

Study Arms (2)

CoCr-BAS

ACTIVE COMPARATOR

Stenting using Optimax™ cobalt-chromium alloy platform with a titanium-nitride-oxide coating

Procedure: Stenting using Optimax™

PtCr-EES

ACTIVE COMPARATOR

Stenting using PROMUS Element™ Plus durable polymer everolimus-eluting stent built on a platinum-chromium platform.

Procedure: Stenting using PROMUS Element™ Plus

Interventions

Stenting using Optimax™ PROCEDURE

CoCr-BAS

Stenting using PROMUS Element™ Plus PROCEDURE

PtCr-EES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• 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:

• Pre-existing diagnosis of diabetes irrespective of its type
• 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, stainless steel 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 intestigational 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

Sponsors & Collaborators

• The Hospital District of Satakunta: lead

Study Sites (4)

Kokkola Central Hospital

Kokkola, Finland

Location

Heart Center, Kuopio University Hospital

Kuopio, Finland

Location

Heart Center, Satakunta Central Hospital

Pori, 28500, Finland

Location

Heart Center, Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

FI (4)