An interventional study of sirolimus drug coated balloon (SCB) and paclitaxel releasing coronary balloon catheter in Coronary Artery Disease and DCB, sponsored by Concept Medicals BV. Status unknown at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-05.
Sponsored by Concept Medicals BV · Not applicable, Interventional, and Treatment
The study is a prospective, multinational (Italy, Ireland and UK), multicenter, randomised Clinical Trial that compares the efficacy and performance of two drug coated balloon (DCB), the MAGIC TOUCH sirolimus coated balloon (Concept Medical) and SeQuent Please paclitaxel coated balloon (B Braun). The objective of the study is to compare angiographic outcomes of Magic TouchTM sirolimus coated balloon (Concept Medical) versus SeQuentTM paclitaxel coated balloon (Bbraun) 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, multi-centre study in subjects with small vessels, i.e. at least one de-novo lesion in a small vessel (≤2.75mm). Vessel size will be determined first by QCA on-line (screening, pre-procedure). If, based on QCA on-line the vessel size pre-procedure is ≤2.75mm and following a successful pre-dilatation (i.e. no angiographic dissections type CDEF and TIMI>2), the subject will be randomized in a 1:1 fashion to Magic Touch or SeQuent Please Neo. OCT will be performed post pre-dilatation (guidance) prior to drug coated balloon (DCB) treatment. The DCB balloon size will be selected based on OCT measurements.
5,677 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 121 is close to the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →This is the only study on the registry with Concept Medicals BV as lead sponsor.
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Patient with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values
Note: For patients showing elevated Troponin (e.g. non-STEMI patients) at baseline (within 72h pre-PCI) an additional blood sample must be collected prior to randomization to confirm that:
Exclusion Criteria:
Currently participating in another trial and not yet at its primary endpoint.
Angiographic exclusion criteria:
Magic TouchTM (Concept Medical) is a sirolimus drug coated balloon (SCB)
Device: sirolimus drug coated balloon (SCB)
SeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter
Device: paclitaxel releasing coronary balloon catheter
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.
SeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter.
Net Gain (mm) In-segment
The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 6 months post-procedure.
Time frame: 6 Months
Device success
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).
Time frame: Post procedure (Right after the treatment with drug coated balloon)
Procedure Success
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).
Time frame: Post procedure (Right after the treatment with drug coated balloon)
Acute/subacute/early/late vessel closure/thrombosis
Closure by restenosis or thrombosis (diameter stenosis of 100% and/or TIMI grade 0).
Time frame: 1, 6 months and 12 Months
Angiographic outcomes: late lumen loss
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).
Time frame: 6 months
Angiographic outcomes:Minimal lumen diameter
The smallest lumen diameter in the segment of interest
Time frame: 6 months
Angiographic outcomes: Percent diameter stenosis
The percentage of luminal narrowing of vessel segment of interest
Time frame: 6 months
Angiographic outcomes: Restenosis rate
Restenosis is defined as ≥50% diameter stenosis at follow-up.
Time frame: 6 months
Device oriented Composite Endpoint (DoCE / TLF): Cardiac death
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.
Time frame: 1, 6 months and 12 Months
Device oriented Composite Endpoint (DoCE / TLF): Target vessel: myocardial infarction (TV-MI)
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.
Time frame: 1, 6 months and 12 Months
Device oriented Composite Endpoint (DoCE / TLF): clinically indicated target lesion revascularization(TLR)
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.
Time frame: 1, 6 months and 12 Months
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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