NL-OMON51852
Not yet recruiting
Phase 3
Drug-Coated Balloons versus Drug-Eluting Stents for Treatment of De-Novo Coronary Artery Lesions in Patients with Stable Coronary Artery Disease - the COATED Trial. - The COATED Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- arteriosclerosis
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 230
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>\= 18 years
- •Stable angina or dyspnea and the presence of a single de\-novo lesion in a
- •native coronary artery causing myocardial ischemia, eligible for PCI based on a
- •formal local heart team decision
- •Reference diameter of the vessel is 2\.5\-4\.0 mm
- •The lesion is suitable for both treatment with DCB and DES
Exclusion Criteria
- •Dissection affecting the flow (TIMI score\<3\), significant recoil (\>30%) or
- •coronary perforation after predilation
- •Reference diameter of the vessel is \<2\.5 mm or \>4\.0 mm
- •Bifurcation lesion, requiring a two\-stent technique
- •In\-stent restenosis
- •Unprotected left main lesion
- •Chronic total occlusion
- •Acute cononary syndrome
- •Cardiogenic shock
- •Severe kidney disease defined as an eGFR \< 30 ml/min
Outcomes
Primary Outcomes
Not specified
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