Prospective, Single-arm, Multicenter Study for Evaluation the Safety and Effectiveness of the ALEX Stent in a Real-world Setting of Percutaneous Coronary Interventions in Patients With Coronary Heart Disease

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of the ALEX stent in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.

Detailed Description
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Prospective, multicenter, non-randomized study designed to enroll up to 60 subjects to evaluate the safety and effectiveness of the cobalt-chromium sirolimus eluting coronary stent ALEX in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.

Official Title
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Prospective, Single-arm, Multicenter Study for Evaluation the Safety and Effectiveness of the ALEX Stent in a Real-world Setting of Percutaneous Coronary Interventions in Patients With Coronary Heart Disease. Study With Angiography and OCT Follow-up.

Conditions
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Stable Angina, Unstable Angina, Myocardial Infarction

Intervention / Treatment
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* Procedure: Implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALEX stent arm<br>implantation of ALEX stent during index procedure | Procedure: Implantation<br>* index angioplasty with ALEX stent implatation<br>* Other names: ALEX Stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of stent strut coverage and parameters of restenosis | Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) 12 months follow-up after the baseline procedure in group of first 20 patients | at 12 months follow-up | 
| Assessment of stent strut coverage and parameters of restenosis | Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) 6 months follow-up after the baseline procedure in group of second 20 patients | at 6 months follow-up | 
| Assessment of stent strut coverage and parameters of restenosis | Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) at 3 months follow-up after the baseline procedure in group of third 20 patients | at 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Procedural success during baseline PCI assessed in coronary angiography (QCA) | during index hospitalization | 
| Occurrence of stent thrombosis | Occurrence of stent thrombosis at 30 days follow-up | at 30 days follow-up | 
| Occurrence of stent thrombosis | Occurrence of stent thrombosis at 12 months follow-up | at 12 months follow-up | 
| Incidence of Major Adverse Cardiac Events | Incidence of Major Adverse Cardiac Events (MACEs) at 30 days follow-up defined as death, myocardial infarction target lesion re-PTCA or target lesion bypass graft | at 30 days follow-up | 
| Incidence of Major Adverse Cardiac Events | Incidence of Major Adverse Cardiac Events (MACEs) at 12 months follow-up defined as death, myocardial infarction target lesion re-PTCA or target lesion bypass graft | at 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALEX, coronary stent, cobalt-chromium, sirolimus, OCT