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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)

Primary Purpose

Stable Angina, Unstable Angina, Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Implantation
Sponsored by
Balton Sp.zo.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina focused on measuring ALEX, coronary stent, cobalt-chromium, sirolimus, OCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carint Scanmed Szpital Sw. Rafala
  • Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Zakladu Hemodynamiki i Angiografii
  • Polsko-Amerykanskie Kliniki Serca I Oddzial Kardiologiczno-Angiologiczny
  • Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
  • Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Kardiologii Inwazyjnej

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALEX stent arm

Arm Description

implantation of ALEX stent during index procedure

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Procedural success
Procedural success during baseline PCI assessed in coronary angiography (QCA)
Occurrence of stent thrombosis
Occurrence of stent thrombosis at 30 days follow-up
Occurrence of stent thrombosis
Occurrence of stent thrombosis 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
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

Full Information

First Posted
July 6, 2012
Last Updated
March 12, 2014
Sponsor
Balton Sp.zo.o.
Collaborators
KCRI
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1. Study Identification

Unique Protocol Identification Number
NCT01637012
Brief 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
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balton Sp.zo.o.
Collaborators
KCRI

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Unstable Angina, Myocardial Infarction
Keywords
ALEX, coronary stent, cobalt-chromium, sirolimus, OCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALEX stent arm
Arm Type
Experimental
Arm Description
implantation of ALEX stent during index procedure
Intervention Type
Procedure
Intervention Name(s)
Implantation
Other Intervention Name(s)
ALEX Stent
Intervention Description
index angioplasty with ALEX stent implatation
Primary Outcome Measure Information:
Title
Assessment of stent strut coverage and parameters of restenosis
Description
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
Time Frame
at 12 months follow-up
Title
Assessment of stent strut coverage and parameters of restenosis
Description
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
Time Frame
at 6 months follow-up
Title
Assessment of stent strut coverage and parameters of restenosis
Description
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
Time Frame
at 3 months follow-up
Secondary Outcome Measure Information:
Title
Procedural success
Description
Procedural success during baseline PCI assessed in coronary angiography (QCA)
Time Frame
during index hospitalization
Title
Occurrence of stent thrombosis
Description
Occurrence of stent thrombosis at 30 days follow-up
Time Frame
at 30 days follow-up
Title
Occurrence of stent thrombosis
Description
Occurrence of stent thrombosis at 12 months follow-up
Time Frame
at 12 months follow-up
Title
Incidence of Major Adverse Cardiac Events
Description
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
Time Frame
at 30 days follow-up
Title
Incidence of Major Adverse Cardiac Events
Description
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
Time Frame
at 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Legutko, MD, PhD
Organizational Affiliation
Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dariusz Dudek, Prof.
Organizational Affiliation
Szpital Uniwersytecki w Krakowie, ul. Kopernika 17, Krakow 31-501, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Carint Scanmed Szpital Sw. Rafala
City
Krakow
State/Province
Bochenka 12
ZIP/Postal Code
30-693
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Zakladu Hemodynamiki i Angiografii
City
Krakow
State/Province
Kopernika 17
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Polsko-Amerykanskie Kliniki Serca I Oddzial Kardiologiczno-Angiologiczny
City
Ustron
State/Province
Sanatoryjna 7
ZIP/Postal Code
43-450
Country
Poland
Facility Name
Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
City
Dabrowa Gornicza
State/Province
Szpitalna 13
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Kardiologii Inwazyjnej
City
Warszawa
State/Province
Woloska 137
ZIP/Postal Code
02-507
Country
Poland

12. IPD Sharing Statement

Links:
URL
http://www.balton.pl/
Description
Sponsor

Learn more about this trial

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

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