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Clinical Trials/DRKS00011630
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.

Registry
who.int
Start Date
February 13, 2017
End Date
January 31, 2015
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Clinical hospital center Rijeka

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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