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.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51852

Enrollment

230

Registered

2022-09-06

Start date

2025-06-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arteriosclerosis coronary artery disease

Interventions

After inclusion, patients will be randomized (1:1) to treatment with DCB or DES. Patients in DES group receive DAPT for 6 months (clopidogrel + aspirin), followed by life-long treatment with a singl

Eligibility

Age

18 Years to 99 Years

Inclusion 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

Exclusion criteria: • Dissection affecting the flow (TIMI score30%) or coronary perforation after predilation • Reference diameter of the vessel is 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

Design outcomes

Primary

Measure	Time frame
The primary objective is to investigate percentage diameter stenosis at 1-year follow-up as assessed by coronary angiography in patients with a single de-novo lesion in a native coronary artery successfully treated with DCB as compared to treated with DES.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)