NL-OMON54743
Recruiting
Not Applicable
Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease - BioVasc Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 794
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
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
- •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
Outcomes
Primary Outcomes
Not specified
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