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

Myocardial Infarction Clinical Trial

— ALEX OCT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637012
• Other study ID #: 2.0, 2011-12-01
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2012
• Last updated: March 12, 2014
• Start date: February 2012
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Balton Sp.zo.o.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Infarction
• Myocardial Ischemia
• Stable Angina
• Unstable Angina

Intervention

Procedure:
• Implantation
index angioplasty with ALEX stent implatation

Locations

Country	Name	City	State
Poland	Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii	Dabrowa Gornicza	Szpitalna 13
Poland	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

Sponsors (2)

Lead Sponsor	Collaborator
Balton Sp.zo.o.	KCRI

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Procedural success	Procedural success during baseline PCI assessed in coronary angiography (QCA)	during index hospitalization	No
Secondary	Occurrence of stent thrombosis	Occurrence of stent thrombosis at 30 days follow-up	at 30 days follow-up	No
Secondary	Occurrence of stent thrombosis	Occurrence of stent thrombosis at 12 months follow-up	at 12 months follow-up	No
Secondary	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	Yes
Secondary	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	Yes

External Links

•   Core Laboratory
•   Sponsor