Status:
COMPLETED
Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Jeju National University Hospital
Chungbuk National University Hospital
Conditions:
Coronary Artery Disease
Coronary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this multicenter, randomized, open label, parallel arm study whether the newest 3rd generation stent - Orsiro hybrid sirolimus-eluting stent is noninferior to the newest 2nd generation ...
Detailed Description
The rate of restenosis after percutaneous coronary intervention (PCI) has dramatically decreased since the introduction of drug-eluting stents (DES). However, restenosis still remains a problem and so...
Eligibility Criteria
Inclusion
- Subject must be at least 18 years of age.
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the Orsiro Hybrid DES® or Endeavor Resolute Integrity® stent.
- He/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, acute myocardial infarction, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia) with a coronary artery or graft vessel lesion with \>50% stenosis by visual estimation or \>70% stenosis irrespective of the functional status.
- Target lesion(s) must be located in a coronary artery with estimated reference diameter of ≥ 2.5 mm and ≤ 5.0 mm.
- Target lesion(s) must be amenable for PCI.
Exclusion
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Sirolimus, Zotarolimus, Cobalt chromium, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.)
- Patients who cannot maintain aspirin, plavix from the study enrollment to study completion (during 1 year).
- Systemic (intravenous) Sirolimus or Zotarolimus use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Planned major non-cardiac surgery within the study period.
- Patients in cardiogenic shock
- Patients with symptomatic heart failure that preclude coronary angiography in supine position.
- Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT01826552
Start Date
September 1 2013
End Date
June 1 2015
Last Update
April 20 2016
Active Locations (8)
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1
Korea University Ansan Hospital
Ansan, South Korea
2
Chungbuk University Hospital
Cheongju-si, South Korea
3
Inje University Ilsan Paik Hospital
Ilsan, South Korea
4
Inha University Hospital
Incheon, South Korea