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Title

Magic Touch™ sirolimus coated balloon (Concept Medical) versus SeQuent™ paclitaxel coated balloon (BBraun) for the treatment of de novo coronary artery lesions in small coronary vessels
Manish doshi Manish Doshi,
Founder & CEO Concept Medical
"Magic Touch is among the first Sirolimus eluting DCBs to receive the CE mark. To overcome the DES limitations, DCB have been developed in recent years; these balloons are covered with an antiproliferative drug that is rapidly released when in contact with the vessel wall. "
Serruys Prof. Partick W. Serruys
Chairman
"We hope that this study will provide proof of the strength of the Magic Touch (Sirolimus coated) balloon versus the Paclitaxel coated balloons"
Cortese Dr. Bernardo Cortese
Chairman
"We struggled in the last couple of years in order to have one of the most modern and scientifically attractive study design, including optical-coherence tomography for lesion assessment. We look forward to enrolling all the patients as soon as possible by an extraordinary group of Investigators."
Colombo Prof. Antonio Colombo
Principal Investigator
"Transform I is launching a new standard in Drug Coated Balloon technology let us enthusiastically make this study move forward."

 

Study Details

  • Objective

    • The objective of the study is to compare angiographic outcomes of Magic Touch sirolimus coated balloon (Concept Medical) versus SeQuent Please Neo paclitaxel coated balloon (B.braun) for the treatment of de novo coronary artery lesions in small vessels (≤2.75 mm) with respect to Net Gain (mm) at 6 months follow-up

    • A prospective, randomized, multicenter study in subjects with small vessels, i.e. at least one de-novo lesion in a small vessel (≤2.75mm)

    •OCT will be performed post pre-dilatation (guidance) prior to DCB treatment

    • The DCB balloon size will be selected based on OCT measurements

  • Endpoints

    Primary Endpoints:
    The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 6 months post-procedure.

    Secondary Endpoints:
    Device success (Lesion based); Procedure success; Angiographic outcomes (late lumen loss, minimal lumen diameter, percent diameter stenosis, restenosis rate); Device oriented Composite Endpoint (DoCE / TLF) defined as the composite of cardiac death, TV-MI, and clinically indicated target lesion revascularization (TLR); Acute/subacute/early/late vessel closure/thrombosis.

  • Clinicaltrials.gov

    NCT03913832

Study Countries

Patients Enrolled

109

Italy

  • Study PI

     – Prof. Antonio Colombo

  • Maria Cecilia Hospital, Cotignola

     – Dr. Roberto Nerla

  • AOU Careggi, Florence

     – Prof. Carlo Di Mario  

  • Policlinico San Donato, San Donato

     – Prof. Luca Testa 

  • Humanitas Research Hospital IRCSS, Rozzano

    -Dr. Bernhard Reimers

     

UK

  • Heartlands Hospital, Bordesley Green Birmingham

     – Dr. Sandeep Basavarajaiah

Ireland

  • NUI Galway, Ireland

     – Dr. Faisal Sharif

Sponsor

Concept Medical B.V

Hogebrinkerweg 33,

3871KM Hoevelaken,

The Netherlands.

Concept Medical Research Pvt. Ltd.

Office 901~903, Trinnity Orion,

Beside Jolly Residency, Vesu,

Surat-395007, Gujarat, India.

Concept Medical Inc.

5600 Mariner ST, STE 200,

Tampa, FL 33609,

USA

Concept Medical PTE Ltd

3 Shenton Way, #12-08 Shenton House,

Singapore 068805