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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT01171820
Eligibility Criteria:
Inclusion Criteria:
* at least 18 years
* able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
* diagnosed with diabetes, as documented by medical history.
* evidence of myocardial ischemia
* acceptable candidate for coronary artery bypass grafting (CABG) surgery
* agree to undergo all clinical investigation plan (CIP)-required follow-up examinations
* artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
* maximum of one, de novo, target lesion per native major epicardial vessel or side branch
* target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
* target lesion ≤ 28 mm in length by visual estimate
* target lesion must be in a major artery or branch with a visually estimated stenosis of \> 50% and \< 100% and a TIMI flow \> 1
Exclusion Criteria:
* known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
* current unstable arrhythmias
* Left ventricular ejection fraction \< 30%
* received a heart or any other organ transplant or is on a waiting list for any organ transplant
* receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
* receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
* known hypersensitivity or contraindication to specific agents
* elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
* platelet count limits, white blood cell limits or documented or suspected liver disease
* renal insufficiency
* history of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Cerebrovascular accident or transient ischemic attack within the past 6 months
* significant GI or urinary bleed within the past 6 months
* history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
Target lesion meets any of the following criteria:
* In-stent restenotic
* aorto-ostial location (within 3 mm)
* left main location
* located within 2 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX)
* located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and \> 20% stenosed lesion by visual estimation)
* lesion involving a side branch ≥ 2.5 mm in diameter
* lesion involving a side branch with \> 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation
* located in a major epicardial vessel that has been previously treated with brachytherapy
* located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), \< 9 months prior to the index procedure
* total occlusion (TIMI flow 0), prior to wire crossing
* excessive tortuosity proximal to or within the lesion
* extreme angulation (≥ 90%) proximal to or within the lesion
* heavy calcification
The target vessel contains visible thrombus
Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)
Patient has additional clinically significant lesion(s) (\> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01171820
Study Brief:
Protocol Section:
NCT01171820