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

NCT ID: NCT01637012

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-09-30

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.

Conditions

Stable Angina; Unstable Angina; Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ALEX stent arm

implantation of ALEX stent during index procedure

Group Type: EXPERIMENTAL

Implantation

Intervention Type: PROCEDURE

index angioplasty with ALEX stent implatation

Interventions

Implantation

index angioplasty with ALEX stent implatation

Intervention Type: PROCEDURE

Other Intervention Names

ALEX Stent

Eligibility Criteria

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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCRI

OTHER

Sponsor Role: collaborator

Balton Sp.zo.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacek Legutko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland

Dariusz Dudek, Prof.

Role: STUDY_CHAIR

Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland

Locations

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

Ustroń, Sanatoryjna 7, Poland

Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii

Dąbrowa Górnicza, Szpitalna 13, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Kardiologii Inwazyjnej

Warsaw, Woloska 137, Poland

Countries

Poland

Related Links

http://www.balton.pl/

Sponsor

Other Identifiers

2.0, 2011-12-01

Identifier Type: -

Identifier Source: org_study_id