Status:
COMPLETED
Comparison of Biomatrix and Orsiro Drug Eluting Stent
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Wonju Severance Christian Hospital
Korea University Guro Hospital
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The primary objective of the BIODEGRADE study is to evaluate clinical efficacy of the Orsiro drug-eluting stent compared with Biomatrix drug-eluting stent, both of which have biodegradable polymer for...
Detailed Description
The rate of in-stent restenosis after percutaneous coronary intervention (PCI) has decreased since the launching of drug-eluting stents (DES). However, restenosis still remains a problem since PCI is ...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- 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 Biomatrix flex stents or Orsiro stents, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have significant lesion (\>50% by visual estimate) in any of the coronary arteries, venous or arterial bypass grafts.
- Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia). In subjects with diameter stenosis \> 70%, evidence of myocardial ischemia does not have to be documented.
- Angiographic Inclusion Criteria
- Target lesion(s) must be located in coronary artery, venous or arterial bypass graft with diameter of ≥ 2.5 mm and ≤ 4.5 mm.
- Target lesion(s) must be amenable for percutaneous coronary intervention.
Exclusion
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Cilostazol, Prasugrel, Ticagrelor, Biolimus, Sirolimus, 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.)
- Systemic (intravenous) Biolimus or Sirolimus 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, known coagulopathy (including heparin- induced thrombocytopenia), abnormal hemogram (Hb\<10g/dL or PLT count \<100,000/μL) or will refuse blood transfusions
- Patients with severe LV systolic dysfunction (LVEF\<25%) or cardiogenic shock
- Gastrointestinal or genitourinary bleeding within the prior 2 months, or major surgery within 2 months.
- 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.
- Symptomatic heart failure
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
2341 Patients enrolled
Trial Details
Trial ID
NCT02299011
Start Date
July 1 2014
End Date
September 1 2019
Last Update
September 25 2019
Active Locations (1)
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1
Seoul National Universtiy Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707