Status:
TERMINATED
Plasmonic Photothermal and Stem Cell Therapy of Atherosclerosis Versus Stenting
Lead Sponsor:
Ural State Medical University
Collaborating Sponsors:
Ural Institute of Cardiology
De Haar Research Foundation
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
45-65 years
Phase:
PHASE1
Brief Summary
Intensive therapy with rosuvastatin 40 mg and ApoA-I Milano reduces the total atheroma volume (TAV) up to 6.38 or 14.1 mm3 respectively. Our previous bench studies PLASMONICS and NANOM First-in-Man tr...
Detailed Description
Nanoparticles (NPs) are quite safe for an organism but entire kinetics is mostly unknown. The most dangerous approach with lowest level of efficacy and safety is a delivery of NPs with microbubbles. S...
Eligibility Criteria
Inclusion
- Multivessel coronary artery disease without indications for CABG
- Stable angina with indications for preventive PCI
- NSTEMI (primary PCI and late comers) \<=\> 12 hr
- STEMI with kept EF\>50% (all comers)
- Rescue PCI
- Vessel size between 2.3-4.0 mm
- NYHA II-III functional class of HF
- De novo treatment = no history of PCI or CABG
- Atherosclerosis of proximal left anterior descending artery \<50% stenosis
- Treated hypertension
- Signed written informed consent
Exclusion
- History of MI
- History of CABG or PCI
- Indications for CABG
- Contraindications for CABG, PCI
- History of unstable angina, coronary artery syndrome
- History of arrhythmias
- History of stroke
- NYHA I, IV functional class of HF
- Diabetes (fasting glucose \> 7.0 mM/L)
- Untreated hypertension
- Asthma
- Participation to any drug-investigations during previous 60 days
- Pregnancy
- Intolerance to any limus drugs, aspirin, clopidogrel, aspirin, metals and polymers of stent and nanoparticles
- Need for chronic treatment with anti-vitamin K drugs
- Impossibility of clinical follow-up
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01436123
Start Date
December 1 2010
End Date
October 1 2012
Last Update
May 19 2015
Active Locations (3)
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1
De Haar Research Foundation
Rotterdam, South Holland, Netherlands, 3071PR
2
Ural Center of Modern Nanotechnologies, Institute of Natural Sciences, Ural Federal University
Yekaterinburg, Sverdlovsk Oblast, Russia, 620000
3
Ural Institute of Cardiology
Yekaterinburg, Sverdlovsk Oblast, Russia, 620144