Sirolimus-coated balloon versus drug-eluting stent in native coronary vessels

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22515

Enrollment

1130

Registered

2021-08-04

Start date

2021-09-30

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Coronary artery disease

Interventions

Percutaneous Coronary Intervention

Eligibility

Inclusion criteria

Inclusion criteria: - age >18 years; - all patients with a clinical indication to PCI (stable coronary artery disease or acute coronary syndromes); - native coronary artery lesion in a vessel with diameter >2.0 mm and ?3.0 mm at visual estimation; - maximum lesion lenght: 40 mm. - informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: - patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus or contrast media, which cannot be adequately pre-medicated; - patients participating in another clinical study; - subject is a woman who is pregnant or nursing (pregnancy test, either urine or blood test must be performed within 7 days prior to the index procedure in woman of child-bearing potential, and must not commit to initiating a pregnancy for 12 weeks after implantation, using effective contraception); - creatinine clearance 99% and/or TIMI flow 30%); - severe calcification of the target vessel, at lesion site but also proximally; - highly tortuous vessel which could impair device delivery to the lesion site following Investigator’s judgement; - previous stent implantation at target vessel (left anterior descending artery; circumflex artery; right coronary artery); - bifurcation lesion where side branch treatment is anticipated; - left main stem stenosis >50%; - target lesion is in left main stem

Design outcomes

Primary

Measure	Time frame
To verify the non-inferiority of Magic Touch SCB hypothesized in target lesion failure (TLF), a composite of cardiac death, ischemia-driven target lesion revascularization (TLR), target vessel myocardial infarction (MI), at 12 months	—

Secondary

Measure	Time frame
-cardiac death; -all-cause death; -Q-wave MI; -any MI; -TLR; -target vessel revascularization; -vessel thrombosis; -bleedings following BARC classification.	—

Contacts

Public ContactBernardo Cortese

Fondazione Ricerca e Innovazione Cardiovascolare ETS

transform2study@gmail.com+39 351 819 3194

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)