Transform 1 - Randomized Controlled trial for Sirolimus Coated Balloon
Transform I


  • Lead Investigator – Antonio Colombo
    Study Chair – Patrick W. Serruys

• 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 (≤2.5 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 (≤2.5mm).

Study 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.

Transform I