Status:
UNKNOWN
Polish-Italian-Hungarian RAndomized ThrombEctomy Trial
Lead Sponsor:
Jagiellonian University
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Aim Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy system leading to thrombus reduction. Study design: Multicenter, prospective, opened, randomized. Primar...
Eligibility Criteria
Inclusion
- ST elevation acute myocardial infarction within 6 hours since pain onset, with 2 mm ST segment elevation in two lead
- Minimum 3 mm ST segment elevation in one leads
- Vessel reference diameter \> 2.5 mm
- When vessel reference diameter ≥ 4,0 mm than additional distal protection device (filter) is needed during stent implantation
Exclusion
- Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors
- Active bleeding or coagutopathy
- Prior CABG or PCI
- Known ejection fraction EF \<35%
- Cardiogenic shock /SBP \< 90 mmHg, IABP and/or catheloamins usage/
- LBBB, pacemaker rhythm
- Severe calcifications
- Previous Myocardial infarction
- Stroke history
- Patient directly after reanimation
- Known thrombocytopenia- platelets \< 100 000
- Pregnancy
- Cancer disease
- No future patient cooperation expected
- Patient's taking part in the other clinical trials
- Fibrynolisis directly administered before PCI
- Renal insufficiency (creatynine \> 220 µmol/ml), hemodialysis
- Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors
- Active bleeding or coagutopathy
- Prior CABG or PCI
- Known ejection fraction EF \<35%
- Cardiogenic shock /SBP \< 90 mmHg, IABP and/or catheloamins usage/
- LBBB, pacemaker rhythm
- Severe calcifications
- Previous Myocardial infarction
- Stroke history
- Patient directly after reanimation
- Known thrombocytopenia- platelets \< 100 000
- Pregnancy
- Cancer disease
- No future patient cooperation expected
- Patient's taking part in the other clinical trials
- Fibrynolisis directly administered before PCI
- Renal insufficiency (creatynine \> 220 µmol/ml), hemodialysis
- Liver insufficiency
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00377650
Start Date
September 1 2005
End Date
December 1 2007
Last Update
January 17 2007
Active Locations (9)
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1
Institute, Medical School of University Pecs
Pécs, Hungary
2
Cardiology Department Hospital Villascassi
Genova, Italy
3
Institute of Cardiology, Catholic University
Rome, Italy
4
Górnośląskie Centrum Medyczne
Katowice, Poland