NCT00494247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 22, 2010

Status Verified

November 1, 2009

Enrollment Period

1.7 years

First QC Date

June 28, 2007

Last Update Submit

June 18, 2010

Conditions

Acute Coronary SyndromesCoronary Heart Disease

Keywords

acute coronary syndromesendothelial progenitor cellscoronary stent

Outcome Measures

Primary Outcomes (3)

  • Safety: MACE (composite CV death, myocardial infarction, heart failure, target vessel revascularization, target lesion revascularization)

    30 days, 3, 6, 9, 12 months

  • Neointima volume measured by IVUS

    6 months

  • In-stent late lumen loss and binary restenosis measured by QCA

    6 months

Secondary Outcomes (7)

  • In stent thrombosis (angiographic, clinical)

    6 months

  • Clinical status (treadmill stress test)

    30 days, 6 months, 12 months

  • Number, function (migration, eNOS expression), transcriptional activity of circulating EPCs

    prior to procedure, 24 hours, 7 days, 1 and 6 months after

  • In segment late lumen loss, EEM area (QCA, IVUS)

    6 months

  • Reactivity of target vessel to adenosine and nitroglycerine (QCA, Doppler)

    6 months

  • +2 more secondary outcomes

Interventions

coronary stent (Genous, OrbusNeich) with immobilised anti-CD34 antibody to capture circulating endothelial progenitor cellsDEVICE

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)

Also known as: Genous, OrbusNeich

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Silesian School of Medicine, 3rd Division of Cardiology

Katowice, 40-635, Poland

Location

American Heart of Poland

Ustroń, Poland

Location

Related Publications (3)

  • Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden EP, Sianos G, van der Giessen WJ, Regar E, de Feyter PJ, Davis HR, Rowland S, Kutryk MJ. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol. 2005 May 17;45(10):1574-9. doi: 10.1016/j.jacc.2005.01.048.

    PMID: 15893169BACKGROUND

  • Silber S. Capturing circulating endothelial progenitor cells: a new concept tested in the HEALING studies. Minerva Cardioangiol. 2006 Feb;54(1):1-3. No abstract available.

    PMID: 16467737BACKGROUND

  • Wojakowski W. Endothelial progenitor cell capture stents - practical use of cell mobilisation. ESC Cardio Website e-Journal Article. February 27, 2007

    BACKGROUND

Related Links

MeSH Terms

Conditions

Acute Coronary SyndromeCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Wojciech Wojakowski, MD, PhD

    Silesian School of Medicine, Katowice, Poland

    PRINCIPAL INVESTIGATOR

  • Michal Tendera, MD, PhD

    Silesian School of Medicine, Katowice, Poland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 28, 2007

First Posted

June 29, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

June 22, 2010

Record last verified: 2009-11

Locations

PL(2)