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.

Phase 3

Conditions: arteriosclerosis
coronary artery disease
10011082

Registration Number: NL-OMON51852

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 230

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
• Pregnancy
• Life expectancy < 12 months
• Inability to give written consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to investigate percentage diameter stenosis at 1-year<br /><br>follow-up as assessed by coronary angiography in patients with a single de-novo<br /><br>lesion in a native coronary artery successfully treated with DCB as compared to<br /><br>treated with DES.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary invasive imaging objectives are minimal lumen diameter, late luminal<br /><br>loss, in-segment binary restenosis, and target vessel re-occlusion at 1-year<br /><br>follow-up. Secondary clinical objectives are evaluation of the occurrence of<br /><br>major adverse cardiac events (MACE) at 1-year follow-up.</p><br>