Drug coated balloon versus drug eluting stent in primary percutaneous coronary intervention: a feasibility study.

Phase 1

• Conditions: I21; Acute myocardial infarction

• Registration Number: DRKS00011630
• Lead Sponsor: Clinical hospital center Rijeka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-01-31
• Study Start: 2017-02-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified