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 (ALEX OCT)

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.

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Stable Angina; Unstable Angina
• Intervention / Treatment: Procedure: Implantation

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Bochenka 12
    • Krakow, Bochenka 12, Poland, 30-693
      • Carint Scanmed Szpital Sw. Rafala
  • Kopernika 17
    • Krakow, Kopernika 17, Poland, 31-501
      • Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Zakladu Hemodynamiki i Angiografii
  • Sanatoryjna 7
    • Ustron, Sanatoryjna 7, Poland, 43-450
      • Polsko-Amerykanskie Kliniki Serca I Oddzial Kardiologiczno-Angiologiczny
  • Szpitalna 13
    • Dabrowa Gornicza, Szpitalna 13, Poland, 43-300
      • Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
  • Woloska 137
    • Warszawa, Woloska 137, Poland, 02-507
      • Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Kardiologii Inwazyjnej

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALEX stent arm; implantation of ALEX stent during index procedure	Procedure: Implantation; index angioplasty with ALEX stent implatation; Other Names: ALEX Stent

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Balton Sp.zo.o.
• Collaborators: KCRI
• Investigators: Principal Investigator: Jacek Legutko, MD, PhD, Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland; Study Chair: Dariusz Dudek, Prof., Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland

Publications and helpful links

Helpful Links

• Sponsor

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 6, 2012
• First Posted (Estimate): July 10, 2012

Study Record Updates

• Last Update Posted (Estimate): March 13, 2014
• Last Update Submitted That Met QC Criteria: March 12, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: OCT; sirolimus; coronary stent; ALEX; cobalt-chromium
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: 2.0, 2011-12-01