Comparison of Biomatrix and Orsiro Drug Eluting Stent

• Status: Completed
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

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 the treatment of all-comers' coronary artery diseases.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Collaborators: Chungnam National University Hospital; Gachon University Gil Medical Center; Gangnam Severance Hospital; KangWon National University Hospital; Korea University Anam Hospital; Korea University Guro Hospital; Kosin University Gospel Hospital; The Catholic University of Korea; Wonju Severance Christian Hospital

Criteria

Inclusion Criteria:

1. General Inclusion Criteria

1. Subject must be at least 18 years of age.

2. 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.

3. Subject must have significant lesion (>50% by visual estimate) in any of the coronary arteries, venous or arterial bypass grafts.

4. 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.

2. Angiographic Inclusion Criteria

1. Target lesion(s) must be located in coronary artery, venous or arterial bypass graft with diameter of ≥ 2.5 mm and ≤ 4.5 mm.

2. Target lesion(s) must be amenable for percutaneous coronary intervention.

Exclusion Criteria:

1. 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.)

2. Systemic (intravenous) Biolimus or Sirolimus use within 12 months.

3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.

4. 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

5. Patients with severe LV systolic dysfunction (LVEF<25%) or cardiogenic shock

6. Gastrointestinal or genitourinary bleeding within the prior 2 months, or major surgery within 2 months.

7. 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).

8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow- up period.

9. Symptomatic heart failure