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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT01925794
Eligibility Criteria:
General Inclusion Criteria:
1. Patient \>/= to 18 years old.
2. Eligible for percutaneous coronary intervention (PCI).
3. Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
4. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
5. Acceptable candidate for coronary artery bypass graft (CABG) surgery.
6. Stable angina pectoris (Canadian Cardiovascular Society (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ETT, SPECT, Stress echocardiography or Cardiac CT).
7. Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).
Angiographic Inclusion Criteria
1. Patient indicated for elective stenting of a single stenotic lesion in a native coronary artery.
2. Reference vessel \>/= 2.5 mm and \</= 4.0 mm in diameter by visual estimate.
3. Target lesion \</= 24 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length).
4. Protected left main lesion with \>50% stenosis.
5. Target lesion stenosis \>/= 70% and \< 100% by visual estimate.
6. Target lesion stenosis \<70% who meet physiological criteria for revascularization (i.e. positive FFR).
General Exclusion Criteria:
1. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
2. Previously enrolled in another stent trial within the prior 2 years.
3. ANY planned elective surgery or percutaneous intervention within the subsequent 3 months.
4. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
5. The patient requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
6. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
7. Previous drug eluting stent (DES) deployment anywhere in the target vessel.
8. Any previous stent placement within 15 mm (proximal or distal) of the target lesion.
9. Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
10. Concurrent medical condition with a life expectancy of less than 12 months.
11. Documented left ventricular ejection fraction (LVEF) \< 30% within 12 months prior to enrollment.
12. Patients with diagnosis of MI within 72 hours (i.e. CK-MB must be returned to normal prior to enrollment) or suspected acute MI at time of enrollment
13. Previous brachytherapy in the target vessel.
14. History of cerebrovascular accident or transient ischemic attack in the last 6 months.
15. Leukopenia (leukocytes \< 3.5 x 10(9) / liter).
16. Neutropenia (Absolute Neutrophil Count \< 1000/mm3) \</= 3 days prior to enrollment.
17. Thrombocytopenia (platelets \< 100,000/mm3) pre-procedure.
18. Active peptic ulcer or active GI bleeding.
19. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
20. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.
21. Serum creatinine level \> 2.0 mg/dl within 7 days prior to index procedure.
22. Patients unable to tolerate dual anti-platelets therapy (DAPT) for one month post procedure.
Angiographic Exclusion Criteria
1. Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the LAD or Circumflex artery or a branch thereof).
2. Target vessel with any lesions with greater than 50% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA.
3. Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying \> 50% of the true lumen diameter) at any time.
4. Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
5. Target lesion with side branches \> 2.0mm in diameter.
6. Target vessel is excessively tortuous (two bends \> 90˚ to reach the target lesion).
7. Target lesion is severely calcified.
8. TIMI flow 0 or 1
9. Target lesion is in a bypass graft
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01925794
Study Brief:
Protocol Section:
NCT01925794