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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT01637012
Eligibility Criteria:
Inclusion Criteria:
Clinical Inclusion Criteria:
* \> 18 years of age
* Patient must provide written informed consent prior to procedure using a form that is approved by the local Ethics Committee
* clinical diagnosis of Stable Angina, Unstable Angina or Myocardial Infarction without ST elevation (NSTEMI) or Myocardial Infarction with ST elevation provided the expiry of 72 hours of the onset of symptoms and stable clinical and hemodynamical condition the Patient with patent postinfarcion artery (TIMI 3) and indications for PCI and next stage of revascularization in the other vessels
* earlier effective supply of others lesions in others vessels in case of multivessels disease
* female of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment and utilize reliable birth control for 12 months after enrolment
Angiographic Inclusion Criteria
* target lesion stentosis must be \> 70% (visual estimate)
* Patient eligible for PCI treatment with the ALEX stent system (vessel diameter in range of 2.5 to 4.0 mm and length of lesion that allows to cover a single stent with maximum length of 30 mm in visual evaluation)
Exclusion Criteria:
Clinical Exclusion Criteria
* anticipated inablility of the patient to comply with 12 months of antiplatelet treatment (e. g. elective non-cardiac surgery following stenting, drug intolerance etc.)
* acute or chronic renal failure (serum creatinine \> 2 mg%, GFR \< 60 ml/min/1.73m2)
* left ventricular ejection fraction (LVEF) \< 40%
* cardiogenic shock
* short life expectancy (\< 1 year)
* any significant medical condition which in the investigator's opinion may interference with the Patient's optimal participation in the study
* current participation in another drug or device clinical trail in which there no be reached the primary endpoint or which clinically interferences with trail's enpoints
Angiographic Exclusion Criteria
* chronic total occlusion
* calcified lesion which cannot be successfully dilated
* location of lesions in the winding vessels where there is no possibility of OCT imaging
* target stenosis located in venous or arterial bridge
* unprotected left main coronary disease with \> 50% stenosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01637012
Study Brief:
Protocol Section:
NCT01637012