Industry Professionals - Concept Medical Inc.
Concept Medical Inc. - Best Heart Care Institute in Surat
Industry Professionals - Concept Medical Inc. - Best Heart Care Institute in Surat
Industry Professionals

CHAIRMAN

Antonio Colombo (Ospedale San Raffaele, Milano)

Bernardo Cortese (A.O. Fatebenefratelli, Milano)

heart

EUROPEAN PROSPECTIVE, SPONTANEOUS, MULTICENTER REGISTRY ON SIROLIMUS DRUG-COATED BALLOON

REALWORLD, ALL COMERS PATIENTS

EVOLUTION OF EASTBOURNE OVER A PERIOD

It is our pleasure to announce that now EASTBOURNE study has increased the target enrolment of 2000 patients.

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Purpose

The purpose of this study is to observe and evaluate the performance of a Sirolimus-eluting Drug-Coated Balloon (SCB) for the treatment of any type of coronary lesions, including native vessel disease and in-stent restenosis.

Investigational Device

The SCB that will be used in this study is a semi-compliant polyamide balloon-catheter with low tip profile (0.016”), coated with Sirolimus drug (drug dose of 180μg on 3.0 x 15 mm balloon, drug to excipient ratio of 1:1).

Clinical Follow-Up

Patients will have a clinical follow-up at 1, 6, 12, 24 and 36 months

Primary Endpoint

Target Lesion Revascularization (TLR) at 12 months

Secondary Endpoint

MACE (Major Adverse Cardiac Events) as a composite of cardiac death, myocardial infarction (MI) and TLR at 6, 12, 24 and 36 months;  any individual element of MACE; procedural success (defined as technical and angiographic success in the absence of MACE during hospitalization)

Total number of patients enrolled: 1215 out of 2000

ENROLLING COUNTRIES

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Disclaimer: We hereby declare the above information is updated as on 22nd day of April 2019. This is to take note that the company is not accountable for any further updates thereafter. For any further queries please contact the company at contact@conceptmedicals.com.

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