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

Recruiting

Conditions: Coronary artery disease
stenosis
10011082

Registration Number: NL-OMON54209

Lead Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare, No profit organization

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 315

Inclusion Criteria

age >18 years; -all patients with a clinical indication to PCI (stable
coronary arterydisease or acute coronary syndromes); -native coronary artery
lesion in a vessel with diameter >2.0 mm and *3.5 mm at visual estimation; -
maximum lesion lenght: 50 mm. - informed consent to participate in the study

Exclusion Criteria

target lesion/vessel with any of the following characteristics: - concomitant
PCI at the same vessel with any device (vessels are considered: left anterior
descending, circumflex or right coronary artery); - pre-dilatation of the
target lesion not performed or not successful (residual stenosis >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. -Lesion
is located within asaphenous vein graft

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To verify the non-inferiority of Magic Touch SCB hypothesized in target lesion<br /><br>failure (TLF), a composite of cardiac death, ischemia-driven target-lesion<br /><br>revascularization (TLR), target vessel myocardial infarction (MI), at 12<br /><br>months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-cardiac death;<br /><br>-all-cause death;<br /><br>-Q-wave MI;<br /><br>-any MI;<br /><br>-TLR;<br /><br>-target vessel revascularization;<br /><br>-vessel thrombosis;<br /><br>-bleedings following BARC classification.</p><br>