Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease

Recruiting

Conditions: acute coronary syndrome
heart attack
10011082

Registration Number: NL-OMON54743

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 794

Inclusion Criteria

1. Age >= 18 years or minimum age as required by local regulations
2. The patient is an acceptable candidate for treatment with a drug eluting
stent in accordance with the applicable guidelines on percutaneous coronary
interventions, manufacturer*s Instructions for Use and the Declaration of
Helsinki
3. Patient indication, lesion length and vessel diameter of the target
lesion(s) are according to the *Instructions for Use* that comes with every
Biotronik Orsiro (Sirolimus-Eluting stent) system. Patients should qualify for
both systems before randomization
4. The patient is willing and able to cooperate with study procedures and
required follow up
visits
5. The subject or legal representative has been informed of the nature of the
study and agrees to its provisions and has provided an EC approved written
informed consent, including data privacy authorization
6. diagnosed Acute coronary syndrome according to ESC guidelines/criteria
7. Multivessel disease

Exclusion Criteria

• Age <18 years and > 85 years
• Single coronary vessel disease
• Patients in cardiogenic shock
• Patients who cannot give informed consent or have a life expectancy of less
than 1year
• Absolute contraindications or allergy that cannot be pre-medicated, to
iodinated contrast or to any of the study medications, including both aspirin
and P2Y12 inhibitors.
• Enrollment in another study with another investigational device or drug trial
that has not reached the primary endpoint The patient may only be enrolled
once in the BioVAsc study
• PCI in the previous 30 days.
• Presence of a chronic total occlusion
• Women of childbearing potential who do not have a negative pregnancy test
within 7 days before the procedure and women who are breastfeeding.
• Planned surgery within 6 months of PCI unless dual antiplatelet therapy is
maintained throughout the peri-surgical period

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is defined as the composite of all-cause mortality,<br /><br>nonfatal type 1 myocardial infarction, any unplanned revascularization, and<br /><br>cerebrovascular events (MACCE) at 1-year post intervention.</p><br>

Secondary Outcome Measures