The All-comers Sirolimus-coated Balloon European Registry (NCT03085823) | Clinical Trial Compass
CompletedNot Applicable
The All-comers Sirolimus-coated Balloon European Registry
Italy2,123 participantsStarted 2016-09
Plain-language summary
The purpose of this study is to observe and evaluate the performance of a Sirolimus-eluting Drug Coated Balloon for the treatment of any type of coronary lesions, including native vessel disease and in stent restenosis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* age at least 18
* patients with symptomatic coronary artery disease (including chronic stable angina, silent ischemia, acute coronary syndromes) with clinical indication to percutaneous coronary intervention.
Exclusion Criteria:
* patients with one or more of the following criteria: known (and untreatable) hypersensitivity or contraindication to Aspirin, Heparin, Clopidogrel, Prasugrel, Ticagrelor, Sirolimus, or a sensitivity to contrast media which cannot be adequately pre-medicated.
* patients enrolled in another trial.
Target lesion/vessel with any of the following characteristics:
* successful pre-dilatation not performed in the target lesion, or not efficacious (residual stenosis \>50%);
* severe calcification of the target vessel, also proximal to the lesion;
* highly tortuous lesions which can impair access of device to treatment site.
* visible thrombus at lesion which is not treatable with aspiration.