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)

This study has been completed.
Sponsor:
Collaborator:
Krakow Cardiovascular Research Institute
Information provided by (Responsible Party):
Balton Sp.zo.o.
ClinicalTrials.gov Identifier:
NCT01637012
First received: July 6, 2012
Last updated: March 12, 2014
Last verified: March 2014

July 6, 2012
March 12, 2014
February 2012
September 2013   (final data collection date for primary outcome measure)
  • Assessment of stent strut coverage and parameters of restenosis [ Time Frame: at 12 months follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 6 months follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 3 months follow-up ] [ Designated as safety issue: No ]
    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
Same as current
Complete list of historical versions of study NCT01637012 on ClinicalTrials.gov Archive Site
  • Procedural success [ Time Frame: during index hospitalization ] [ Designated as safety issue: No ]
    Procedural success during baseline PCI assessed in coronary angiography (QCA)
  • Occurrence of stent thrombosis [ Time Frame: at 30 days follow-up ] [ Designated as safety issue: No ]
    Occurrence of stent thrombosis at 30 days follow-up
  • Occurrence of stent thrombosis [ Time Frame: at 12 months follow-up ] [ Designated as safety issue: No ]
    Occurrence of stent thrombosis at 12 months follow-up
  • Incidence of Major Adverse Cardiac Events [ Time Frame: at 30 days follow-up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at 12 months follow-up ] [ Designated as safety issue: Yes ]
    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
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stable Angina
  • Unstable Angina
  • Myocardial Infarction
Procedure: Implantation
index angioplasty with ALEX stent implatation
Other Name: ALEX Stent
Experimental: ALEX stent arm
implantation of ALEX stent during index procedure
Intervention: Procedure: Implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01637012
2.0, 2011-12-01
No
Balton Sp.zo.o.
Balton Sp.zo.o.
Krakow Cardiovascular Research Institute
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
Balton Sp.zo.o.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP