Status:
COMPLETED
Vascular Healing After Deployment of Titanium-nitride-oxide-coated OPTIMAX™ Stent and PROMUS-ELEMENT™ Everolimus-Eluting Stent
Lead Sponsor:
The Hospital District of Satakunta
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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-el...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- A \>30% stenosis proximal or distal to the target lesion that cannot be covered with the same stent
- Diffuse distal disease
- Prior stent in the target vessel
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02280720
Start Date
January 1 2013
End Date
January 1 2014
Last Update
October 31 2014
Active Locations (4)
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1
Kokkola Central Hospital
Kokkola, Finland
2
Heart Center, Kuopio University Hospital
Kuopio, Finland
3
Heart Center, Satakunta Central Hospital
Pori, Finland, 28500
4
Heart Center, Turku University Hospital
Turku, Finland