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

900 PATIENTS AT 20-30 EUROPEAN SITES

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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 and 24 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 and 24 months;  any individual element of MACE; procedural success (defined as technical and angiographic success in the absence of MACE during hospitalization)

MORE THAN 300 PATIENTS ENROLLED

ENROLLING COUNTRIES

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