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

Phase 4

Completed

• Conditions: Myocardial Infarction; Stable Angina; Unstable Angina
• Interventions: Procedure: Implantation

• Registration Number: NCT01637012
• Lead Sponsor: Balton Sp.zo.o.

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-10
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALEX stent arm	Implantation	implantation of ALEX stent during index procedure

Primary Outcome Measures

Name	Time	Method
Assessment of stent strut coverage and parameters of restenosis	at 3 months follow-up	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

Secondary Outcome Measures

Name	Time	Method
Incidence of Major Adverse Cardiac Events	at 12 months follow-up	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
Occurrence of stent thrombosis	at 12 months follow-up	Occurrence of stent thrombosis at 12 months follow-up
Procedural success	during index hospitalization	Procedural success during baseline PCI assessed in coronary angiography (QCA)

Trial Locations

Locations (5)

Carint Scanmed Szpital Sw. Rafala; 🇵🇱 Krakow, Bochenka 12, Poland

Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Zakladu Hemodynamiki i Angiografii; 🇵🇱 Krakow, Kopernika 17, Poland

Polsko-Amerykanskie Kliniki Serca I Oddzial Kardiologiczno-Angiologiczny; 🇵🇱 Ustron, Sanatoryjna 7, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Kardiologii Inwazyjnej; 🇵🇱 Warszawa, Woloska 137, Poland

Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii; 🇵🇱 Dabrowa Gornicza, Szpitalna 13, Poland