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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)

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
  Purpose

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.


Condition Intervention Phase
Stable Angina
Unstable Angina
Myocardial Infarction
Procedure: Implantation
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Balton Sp.zo.o.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: February 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALEX stent arm
implantation of ALEX stent during index procedure
Procedure: Implantation
index angioplasty with ALEX stent implatation
Other Name: ALEX Stent

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637012

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

Additional Information:
CRO  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Balton Sp.zo.o.
ClinicalTrials.gov Identifier: NCT01637012     History of Changes
Other Study ID Numbers: 2.0, 2011-12-01
Study First Received: July 6, 2012
Last Updated: March 12, 2014
Health Authority: Poland: Ethics Committee

Keywords provided by Balton Sp.zo.o.:
ALEX
coronary stent
cobalt-chromium
sirolimus
OCT

Additional relevant MeSH terms:
Angina, Stable
Angina, Unstable
Coronary Artery Disease
Coronary Disease
Heart Diseases
Infarction
Myocardial Infarction
Myocardial Ischemia
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014