Patients with Insulin-Treated Diabetes Mellitus and Coronary Artery Disease treated with Drug-Eluting Balloon Post Drug-Eluting Stent Therapy

Patients with Insulin-Treated Diabetes Mellitus and Coronary Artery Disease treated with Drug-Eluting Balloon Post Drug-Eluting Stent Therapy - IN-DEPTH

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48509

Enrollment

Registered

2019-04-12

Start date

2019-11-26

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

athereosclerosis

Interventions

Standard treatment (drug-eluting stent placement) versus standard treatment with drug-eluting balloon in patients with insulin-dependent diabetes mellitus.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Insulin-treated diabetes mellitus with coronary artery disease, planned for percutaneous coronary intervention with drug-eluting stent.

Exclusion criteria

Exclusion criteria: Unable to provide informed consent.

Design outcomes

Primary

Measure	Time frame
In-stent late lumen loss at 9 months follow-up, measured with optical coherence tomography, after PCI with drug-eluting stent followed by drug-coated balloon compared with in-stent late lumen loss after PCI with drug-eluting stent alone in a single lesion.	—

Secondary

Measure	Time frame
Device Success at 24 hours; Target Lesion Failure (composite of cardiac death, target vessel myocardial infarction, target lesion revascularization) at 9, 12 and 24 months.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)