Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT01486095
Eligibility Criteria:
Inclusion Criteria:
1. Patient older than 18 years
2. The subject has stable or unstable angina pectoris, or a positive functional study for ischemia.
3. The subject is eligible for PCI, and is an acceptable candidate for coronary artery bypass surgery.
4. The subject is male, or if female, has no childbearing potential or has had a negative urine or serum pregnancy test within 7 days of the index procedure and has no intention to become pregnant within a year of the procedure.
5. The subject has signed the informed consent prior to the procedure, and agrees to comply with the follow up requirements.
6. Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1)).
7. Coronary artery with proximal parent vessel reference diameter of 2.75 - 3.75 mm and a branch vessel diameter of ≥ 2.25 mm.
8. The lesion must be at least 50% diameter stenosis within either the MB or SB.
9. Regarding lesion length: lesion should be able to be covered by 2 Xience Prime stents in a Culotte technique, or by a combination of maximally 1 AXXESS and 2 Biomatrix™ Drug Eluting Coronary Stents.
10. The side branch ostium is located at least 12 mm from the left main coronary artery.
11. The angle between the sidebranch and the parent vessel is less than 70°.
Exclusion Criteria:
1. Left ventricular ejection fraction of \< 30%
2. Impaired renal function (serum creatinine \> 2.0 mg/dl)
3. Previous and/or planned brachytherapy of target vessel
4. Lesion of the left main trunk \> 50%, unprotected
5. The target vessel contains intraluminal thrombus.
6. The target lesion shows angiographic evidence of moderate to severe calcification or tortuosity.
7. Known allergies to antiplatelet, anticoagulation therapy, contrast media, everolimus or biolimus, stainless steel, cobalt, chromium, nickel or titanium
8. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
9. Patients with a life expectancy of less than one year
10. Patient currently enrolled in other investigational device or drug trial
11. Patient not able or willing to adhere to follow-up visits
12. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
13. Patients who previously participated in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01486095
Study Brief:
Protocol Section:
NCT01486095