TReAtmeNt of Small Coronary Vessels: MagicTouch Sirolimus Coated Balloon (TRANSFORM I)
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|ClinicalTrials.gov Identifier: NCT03913832|
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : July 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease DCB||Device: sirolimus drug coated balloon (SCB) Device: paclitaxel releasing coronary balloon catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Magic Touch Sirolimus Coated Balloon (Concept Medical) Versus SeQuent Pease Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Small Vessels|
|Actual Study Start Date :||August 28, 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||August 2023|
Experimental: sirolimus drug coated balloon (SCB)
Magic TouchTM (Concept Medical) is a sirolimus drug coated balloon (SCB)
Device: sirolimus drug coated balloon (SCB)
Magic TouchTM (Concept Medical) is a sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and Nano based drug delivery technology. Magic Touch SCB is a product of CMI proprietary drug delivery technology "Nanolute". It is indicated (CE approved) for ISR, small vessels, bifurcation lesions & de novo lesions.
Active Comparator: paclitaxel releasing coronary balloon catheter.
SeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter
Device: paclitaxel releasing coronary balloon catheter
SeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter.
- Net Gain (mm) In-segment [ Time Frame: 6 Months ]The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 6 months post-procedure.
- Device success [ Time Frame: Post procedure (Right after the treatment with drug coated balloon) ]Successful delivery and inflation within 45 seconds of the allocated DCB device at the intended target lesion during an attempt with a DCB not previously used (first use) and successful withdrawal of the device system with attainment of final in-lesion residual stenosis of <30% (by Quantitative Coronary angiography).
- Procedure Success [ Time Frame: Post procedure (Right after the treatment with drug coated balloon) ]Successful delivery and inflation within 45 seconds of the allocated DCB device at all intended target lesion(s) during an attempt with a DCB not previously used (first use) and successful withdrawal of the device system with attainment of final in-lesion residual stenosis of <30% (by QCA) without the occurrence of TLF during the index procedure hospital stay).
- Acute/subacute/early/late vessel closure/thrombosis [ Time Frame: 1, 6 months and 12 Months ]Closure by restenosis or thrombosis (diameter stenosis of 100% and/or TIMI grade 0).
- Angiographic outcomes: late lumen loss [ Time Frame: 6 months ]The difference between the minimum lumen diameter (MLD) immediately after index procedure and the MLD at follow-up as measured in (preferable) identical orthogonal views (MLDpost - MLDfup).
- Angiographic outcomes:Minimal lumen diameter [ Time Frame: 6 months ]The smallest lumen diameter in the segment of interest
- Angiographic outcomes: Percent diameter stenosis [ Time Frame: 6 months ]The percentage of luminal narrowing of vessel segment of interest
- Angiographic outcomes: Restenosis rate [ Time Frame: 6 months ]Restenosis is defined as ≥50% diameter stenosis at follow-up.
- Device oriented Composite Endpoint (DoCE / TLF): Cardiac death [ Time Frame: 1, 6 months and 12 Months ]Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.
- Device oriented Composite Endpoint (DoCE / TLF): Target vessel: myocardial infarction (TV-MI) [ Time Frame: 1, 6 months and 12 Months ]The term myocardial injury should be used when there is evidence of elevated cardiac troponin values (cTn) with at least one value above the 99th percentile upper reference limit (URL) TV-MI: Myocardial Infarction not clearly attributable to a non-target vessel.
- Device oriented Composite Endpoint (DoCE / TLF): clinically indicated target lesion revascularization(TLR) [ Time Frame: 1, 6 months and 12 Months ]TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913832
|Contact: Dario Gattuso||+39 329 246 email@example.com|
|Galway University Hospital||Recruiting|
|Contact: Faisal Sharif|
|Principal Investigator: Faisal Sharif|
|Maria Cecilia Hospital spa||Recruiting|
|Cotignola, Emilia-Romagna, Italy, 48033|
|Contact: Roberto Nerla, Dr. 39 0545 217111 firstname.lastname@example.org|
|Contact: Letizia Lunetto email@example.com|
|Sub-Investigator: Francesco Giannini, Dr|
|Principal Investigator: Roberto Nerla, Dr|
|I.R.C.C.S. Policlinico San Donato||Recruiting|
|San Donato Milanese, Lombardy, Italy, 20097|
|Contact: Luca Testa, Dr. 39 02 527741 firstname.lastname@example.org|
|Principal Investigator: Luca Testa, Dr.|
|AOUC Azienda Ospedaliero-Universitaria Careggi||Recruiting|
|Firenze, Tuscany, Italy, 50134|
|Contact: Carlo di Mario, Dr (+ 39) 055 794 111 email@example.com|
|Principal Investigator: Carlo di Mario, Dr|
|Sub-Investigator: Pierluigi Demola, Dr|
|Sub-Investigator: Alessio Mattesini, Dr|
|Istituto Clinico Humanitas||Recruiting|
|Contact: Bernhard Reimers|
|Principal Investigator: Bernhard Reimers|
|Sub-Investigator: Antonio Mangieri|
|Heart of England NHS Trust, Heartlands Hospital||Recruiting|
|Birmingham, United Kingdom|
|Contact: Sandeep Basavarajaiah, Dr 44 121 424 2000 firstname.lastname@example.org|
|Principal Investigator: Sandeep Basavarajaiah, Dr|
|Study Chair:||Patrick Serruys, Dr||NUIG Imaging CoreLab|
|Principal Investigator:||Bernardo Cortese, Dr||Clinica San Carlo - Paderno Dugnano|