The All-comers Sirolimus-coated Balloon European Registry (EASTBOURNE)
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ClinicalTrials.gov Identifier: NCT03085823
Recruitment Status : Unknown
Verified February 2019 by Bernardo Cortese, Fatebenefratelli and Ophthalmic Hospital. Recruitment status was: Recruiting
First Posted : March 21, 2017
Last Update Posted : February 25, 2019
Fatebenefratelli and Ophthalmic Hospital
Information provided by (Responsible Party):
Bernardo Cortese, Fatebenefratelli and Ophthalmic Hospital
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All patients with a clinical indication for PCI.
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.
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.