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:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT01174433
Eligibility Criteria:
Inclusion Criteria:
General Inclusion Criteria
* Candidate for percutaneous coronary intervention \& emergent coronary artery bypass graft surgery
* Clinical evidence of ischemic heart disease or a positive functional study
* Female patients of childbearing potential has negative pregnancy test within 7 days before trial procedure
* Patient or patient's legal representative provided written informed consent
* Patient agrees to comply with follow-up evaluations
Angiographic Inclusion Criteria
* Target lesion in a single de novo true bifurcation lesion (Medina classification Type 1.1.1; 1.0.1; 0.1.1; 0.0.1) involving a native coronary artery with reference vessel diameter for the proximal main of 2.5 - 5.0 mm, distal main of 2.5 - 5.0 mm, \& side branch RVD of 2.5 - 3.5 mm
* Target lesion in main vessel has stenosis of \> 50% and \<100%
* Syntax score \< 32
Exclusion Criteria:
General Exclusion Criteria
* Known hypersensitivity/contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, or sensitivity to contrast media, which can't be adequately pre-medicated
* Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³, or a white blood cell (WBC) count \<3,000 cells/mm³ within 7 days prior to index procedure
* Serum creatinine level \>170 micromol/L within 7 days prior to index procedure
* Evidence of acute MI within 72 hours of intended trial procedure (defined as: QWMI or NQWMI having CK enzymes \>2X laboratory upper limit of normal in the presence of a confirming cardiac specific biomarker (Troponin I or T)
* Previous stenting anywhere in target vessel
* Percutaneous coronary intervention (PCI) of non-target vessel within 30 days prior to procedure that results in any MAC(C)E event. If non target vessel stent is implanted within 72 hours prior to index procedure, 2 post procedural serial CK or CK-MB measurements must be below investigational site's upper limit of normal
* PCI of non-target vessel within 24 hours prior to procedure
* Planned PCI of the target vessel within 6 months post-procedure
* During index procedure, target lesion requires treatment with device other than PTCA or cutting balloon prior to stent placement
* Documented left ventricular ejection fraction (LVEF) \<30% at most recent evaluation
* History of stroke or transient ischemic attack (TIA) within prior 6 months
* Active peptic ulcer or upper gastrointestinal (GI) bleeding within prior 6 months
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Concurrent medical condition with life expectancy \<12 months
* Currently participating in investigational drug or device trial that's not completed the primary endpoint or that clinically interferes with current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures.
Angiographic Exclusion Criteria
* Target lesion located in native vessel with saphenous vein graft or left/right internal mammary artery (LIMA/RIMA) bypass
* Target lesion has any of following characteristics:
* Severely calcified
* Evidence of thrombus
* Syntax score ≥33
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01174433
Study Brief:
Protocol Section:
NCT01174433