Endothelial Progenitor Cells-capture Stents in Acute Coronary Syndromes (JACK-EPC)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by:
Silesian School of Medicine
ClinicalTrials.gov Identifier:
NCT00494247
First received: June 28, 2007
Last updated: June 18, 2010
Last verified: November 2009
  Purpose

Randomized prospective study to compare the efficiency and safety of EPC-capture stents (Genous, OrbusNeich) and bare metal stents with concommitant high dose atorvastatin in reduction of neointimal formation assessed by quantitative coronary angiography and IVUS. Also the association between the function (transcriptional activity, migration) and number of circulating EPCs and angiographic outcomes will be investigated.


Condition Intervention Phase
Acute Coronary Syndromes
Coronary Heart Disease
Device: coronary stent (Genous, OrbusNeich) with immobilised anti-CD34 antibody to capture circulating endothelial progenitor cells
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Efficiency of High Dose Atorvastatin and Endothelial Progenitor-Capture Stents and Bare Metal Stents in Reduction of Neointimal Formation in Patients With Non ST-Segment Elevation Acute Coronary Syndromes

Resource links provided by NLM:


Further study details as provided by Silesian School of Medicine:

Primary Outcome Measures:
  • Safety: MACE (composite CV death, myocardial infarction, heart failure, target vessel revascularization, target lesion revascularization) [ Time Frame: 30 days, 3, 6, 9, 12 months ] [ Designated as safety issue: Yes ]
  • Neointima volume measured by IVUS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • In-stent late lumen loss and binary restenosis measured by QCA [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In stent thrombosis (angiographic, clinical) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Clinical status (treadmill stress test) [ Time Frame: 30 days, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Number, function (migration, eNOS expression), transcriptional activity of circulating EPCs [ Time Frame: prior to procedure, 24 hours, 7 days, 1 and 6 months after ] [ Designated as safety issue: No ]
  • In segment late lumen loss, EEM area (QCA, IVUS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reactivity of target vessel to adenosine and nitroglycerine (QCA, Doppler) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Stent apposition/complete stent expansion (IVUS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Plasma levels of inflammatory/hematopoietic cytokines [ Time Frame: prior to procedure, 24 hours, 7 days, 1 and 6 months after ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2007
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: coronary stent (Genous, OrbusNeich) with immobilised anti-CD34 antibody to capture circulating endothelial progenitor cells
    coronary stent covered with anti-CD34 antobody, (Genous, R-stent, produced by OrbusNeich). 30 patients will undergo PCI with implantation of Genous stent and 30 patients will receive bare metal stent (BMS)
    Other Name: Genous, OrbusNeich
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 80 years
  • Non ST-segment elevation acute coronary syndrome according to ESC definition (CCS III-IV), including NSTEMI and unstable angina
  • De novo lesion >70% in native coronary artery
  • Target vessel diameter 2.5-4.0mm
  • Target lesion length ≤30mm
  • Lesion can be covered with single stent
  • Informed consent granted

Exclusion Criteria:

  • Pulmonary oedema and cardiogenic shock
  • Left ventricular ejection fraction <30%
  • Diabetes
  • Active bleeding, thrombocytopenia (PLT <100x103/ul), bleeding diathesis
  • Known allergy to aspirin, thienopyridines, heparin
  • Presence of other significant (>70%) coronary stenoses requiring revascularization
  • 3-vessel disease
  • Previous PCI in target vessel
  • Previous CABG
  • Left main stenosis >50%
  • Total occlusion (TIMI0)
  • Chronic total occlusion
  • Target lesion of following morphology:
  • Length >30 mm, target vessel diameter <2.5 or >4.0mm
  • Excessive tortuosity
  • Target lesion involving bifurcation with side branch ≥ 2.5mm and/or requiring stent implantation
  • Target lesion in SVG or LIMA
  • Renal failure
  • Liver failure
  • Malignancy
  • Statin intolerance
  • Pregnancy/lack of adequate contraception
  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: NCT00494247

Locations
Poland
Silesian School of Medicine, 3rd Division of Cardiology
Katowice, Poland, 40-635
American Heart of Poland
Ustron, Poland
Sponsors and Collaborators
Silesian School of Medicine
Ministry of Science and Higher Education, Poland
Investigators
Principal Investigator: Wojciech Wojakowski, MD, PhD Silesian School of Medicine, Katowice, Poland
Study Chair: Michal Tendera, MD, PhD Silesian School of Medicine, Katowice, Poland
  More Information

Additional Information:
Publications:
Responsible Party: Wojciech Wojakowski MD, 3rd Division of Cardiology, Silesian School of Medicine
ClinicalTrials.gov Identifier: NCT00494247     History of Changes
Other Study ID Numbers: N40202932/0651, 0651/P01/2007/32
Study First Received: June 28, 2007
Last Updated: June 18, 2010
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health

Keywords provided by Silesian School of Medicine:
acute coronary syndromes
endothelial progenitor cells
coronary stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Acute Coronary Syndrome
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014