Clinical trial NCT01637012: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stable Angina
Unstable Angina
Myocardial Infarction
Keywords: ALEX
coronary stent
cobalt-chromium
sirolimus
OCT
Lead sponsor: Balton Sp.zo.o.
Sponsor class: INDUSTRY
Collaborators: name: KCRI
First posted: 2012-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessment of stent strut coverage and parameters of restenosis
timeFrame: at 12 months follow-up
measure: Assessment of stent strut coverage and parameters of restenosis
timeFrame: at 6 months follow-up
measure: Assessment of stent strut coverage and parameters of restenosis
timeFrame: at 3 months follow-up
Secondary outcomes:
measure: Procedural success
timeFrame: during index hospitalization
measure: Occurrence of stent thrombosis
timeFrame: at 30 days follow-up
measure: Occurrence of stent thrombosis
timeFrame: at 12 months follow-up
measure: Incidence of Major Adverse Cardiac Events
timeFrame: at 30 days follow-up
measure: Incidence of Major Adverse Cardiac Events
timeFrame: at 12 months follow-up
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Carint Scanmed Szpital Sw. Rafala
state: Bochenka 12
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Zakladu Hemodynamiki i Angiografii
state: Kopernika 17
city: Ustron
country: Poland
facility: Polsko-Amerykanskie Kliniki Serca I Oddzial Kardiologiczno-Angiologiczny
state: Sanatoryjna 7
city: Dabrowa Gornicza
country: Poland
facility: Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
state: Szpitalna 13
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Kardiologii Inwazyjnej
state: Woloska 137
Study officials:
affiliation: Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland
name: Jacek Legutko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland
name: Dariusz Dudek, Prof.
role: STUDY_CHAIR
References: