DRKS00011630
Completed
Phase 1
Drug coated balloon versus drug eluting stent in primary percutaneous coronary intervention: a feasibility study. - DCB vs. DES in pPCI: a feasibility study.
Clinical hospital center Rijeka0 sites75 target enrollmentFebruary 13, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- I21
- Sponsor
- Clinical hospital center Rijeka
- Enrollment
- 75
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria were: 1\) STEMI presenting less than 12 hours from symptoms onset; 2\) de novo lesion: coronary artery occlusion or critical stenosis; 3\) coronary artery diameter from 2\.5 to 4\.0 mm.
Exclusion Criteria
- •Exclusion criteria were: 1\) stroke within the last six months; 2\) likelihood of survival less than one year; 3\) pregnancy or breastfeeding; 4\) The Modification of Diet in Renal Disease (MDRD) derived eGFR \<30 ml/min/1,73 m2; 5\) in stent restenosis; 6\) extensive coronary disease needing additional revascularization; 7\) PCI or coronary artery bypass graft (CABG) surgery within the last six months; 8\) severe coronary artery tortuosity; 9\) hypersensitivity, allergies and other contraindications to acetylsalicylic acid, clopidogrel, heparin, paclitaxel or eptifibatide; 10\) allergies to iodine\-containing contrast medium; 11\) leucocytes count \<3,5 x 10^9/L and platelets count \<75 x 10^9/L or \>650 x 10^9/L.
Outcomes
Primary Outcomes
Not specified
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