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

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ClinicalTrials.gov Identifier: NCT00494247
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : June 22, 2010
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment 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

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : October 2007
Primary Completion Date : June 2009
Study Completion Date : August 2009
Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Safety: MACE (composite CV death, myocardial infarction, heart failure, target vessel revascularization, target lesion revascularization) [ Time Frame: 30 days, 3, 6, 9, 12 months ]
  2. Neointima volume measured by IVUS [ Time Frame: 6 months ]
  3. In-stent late lumen loss and binary restenosis measured by QCA [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. In stent thrombosis (angiographic, clinical) [ Time Frame: 6 months ]
  2. Clinical status (treadmill stress test) [ Time Frame: 30 days, 6 months, 12 months ]
  3. Number, function (migration, eNOS expression), transcriptional activity of circulating EPCs [ Time Frame: prior to procedure, 24 hours, 7 days, 1 and 6 months after ]
  4. In segment late lumen loss, EEM area (QCA, IVUS) [ Time Frame: 6 months ]
  5. Reactivity of target vessel to adenosine and nitroglycerine (QCA, Doppler) [ Time Frame: 6 months ]
  6. Stent apposition/complete stent expansion (IVUS) [ Time Frame: 6 months ]
  7. Plasma levels of inflammatory/hematopoietic cytokines [ Time Frame: prior to procedure, 24 hours, 7 days, 1 and 6 months after ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494247

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
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:
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
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: November 2009

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

Additional relevant MeSH terms:
Heart Diseases
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Immunologic Factors
Physiological Effects of Drugs