Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2004-04-30
2015-11-30
Brief Summary
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Detailed Description
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* Symptomatic patients with a significant stenosis (diameter stenosis \>75% or significant FFR) in a native coronary vessel or a saphenous vein aortocoronary bypass graft.
* All patients are on aspirin (100 mg/day) and received 10,000 I.U. heparin intravenously.
* Coronary angiography is performed via the femoral approach.
* Full informed consent are obtained from all patients before participating in the study.
Stenosis severity/Plaque composition
* Quantification of stenosis severity was performed with the use of off-line caliper measurements (QCA-MEDIS, Leiden, NL).
* Intravascular imaging analyses before and after stent implantation to characterize plaque morphology:
1. IVUS(Eagle-EyeTM 20 MHz catheter and R-100 pullback device, Volcano Corporation, Rancho Cordova, CA, USA)
2. OCT (St. Jude Medical Lightlab C7 Dragonfly Imaging Catheter)
3. NIRS (InfraReDx TVC Insight catheter)
Interventional procedure
Distal balloon occlusion devices:
* TriAktiv SVG/3.5-FX-catheter; Kensey Nash, Exton, USA or
* GuardWire Temporary Occlusion \& Aspiration System; Medtronic Inc., Minneapolis, MN USA Implantation of balloon-expandable stents using balloon pressures between 14 and 18 atm and a balloon-to-vessel diameter ratio of 1:1.
Coronary arterial blood and coronary aspirate
* Coronary arterial blood is taken distal to the lesion before stent implantation and coronary aspirate blood is obtained during stent implantation (each in Heparin- or EDTA- Monovettes, SARSTEDT AG \& Co, Nümbrecht, Germany).
* Ex vivo coronary aspirate blood is filtered through a mesh filter with pores of 40 μm diameter.
* Immediately centrifugation of the filtered coronary arterial and aspirate blood (800g, 10 min, 4°C).
* Particulate debris and coronary arterial and aspirate plasma are quickly frozen in liquid nitrogen and stored at -80°C until further use.
Analysis / Aim :
* Using different methods for determining severity of stenosis and plaque composition.
* Using different biochemical methods to characterize particular and soluble substances released during stenting into coronary aspirate.
* Using different bioassays to study vasoconstrictor potential of human coronary aspirate plasma and the impact. of coronary aspirate on the coronary microcirculation and on cardiac contraction.
* Correlation of ex vivo measurements with patients disease and clinical symptoms.
Conditions
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Study Design
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CROSS_SECTIONAL
Study Groups
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Aspirate Blood
Aspirated Coronary Blood
Coronary arterial blood is taken distal to the lesion before stent implantation and serve as control and coronary aspirate blood is obtained during stent implantation.
Interventions
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Aspirated Coronary Blood
Coronary arterial blood is taken distal to the lesion before stent implantation and serve as control and coronary aspirate blood is obtained during stent implantation.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Universität Duisburg-Essen
OTHER
Responsible Party
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Petra Kleinbongard
scientific assistant
Principal Investigators
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Petra Kleinbongard, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Pathophysiology, University of Essen Medical School
Locations
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Center of Internal Medicine, University of Essen Medical School
Essen, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Horn P, Baars T, Kahlert P, Heiss C, Westenfeld R, Kelm M, Erbel R, Heusch G, Kleinbongard P. Release of Intracoronary Microparticles during Stent Implantation into Stable Atherosclerotic Lesions under Protection with an Aspiration Device. PLoS One. 2015 Apr 27;10(4):e0124904. doi: 10.1371/journal.pone.0124904. eCollection 2015.
Baars T, Konorza T, Kahlert P, Mohlenkamp S, Erbel R, Heusch G, Kleinbongard P. Coronary aspirate TNFalpha reflects saphenous vein bypass graft restenosis risk in diabetic patients. Cardiovasc Diabetol. 2013 Jan 10;12:12. doi: 10.1186/1475-2840-12-12.
Other Identifiers
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ASP-04
Identifier Type: -
Identifier Source: org_study_id