Coronary Artery Disease, DCB
Conditions
Keywords
small vessel, sirolimus, drug coating balloon
Brief summary
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
Detailed description
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.
Interventions
DEVICEsirolimus 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.
DEVICEpaclitaxel releasing coronary balloon catheter
SeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter.
Sponsors
Concept Medicals BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients ≥18 years 2. 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: * hs-cTn or Troponin I or T levels are stable, i.e. the value should be within 20% range of the value found in the first sample at baseline, or have dropped * CK-MB and CK levels are within normal range If hs-cTn or Troponin I or T levels are stable or have dropped, the CK-MB and CK levels are within normal ranges, and the ECG is normal, the patient may be included in the study. 3. The patient has a planned intervention in one or two separate major epicardial territories (LAD, LCX or RCA) and has at least one de-novo lesion in a small vessel (≤2.75mm by QCA prior to pre-dilatation) 4. Target lesion length ≤30 mm 5. Able to understand and provide informed consent and comply with all study procedures including 6 months angiographic follow-up 6. Patient must have completed the follow-up phase of any previous study
Exclusion criteria
1. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential) 2. Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure 3. Known contraindication or hypersensitivity to sirolimus, paclitaxel, or to medications such as aspirin, heparin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor 4. Patient suffered from stroke/TIA during the last 6 months 5. LVEF \<30% 6. Platelet count \<100,000 cells/mm3 or \>400,000 cells/mm3, a WBC of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) 7. Known renal insufficiency (e.g. serum creatinine \>2.5mg/dL, or creatinine clearance ≤30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment) 8. Patient undergoing planned surgery within 6 months with the necessity to stop DAPT 9. History of bleeding diathesis or coagulopathy 10. The patient is a recipient of a heart transplant 11. Concurrent medical condition with a life expectancy of less than 12 months 12. The patient is unwilling/not able to return for angiographic recatherisation at 6 month follow-up 13. Currently participating in another trial and not yet at its primary endpoint. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Gain (mm) In-segment | 6 Months | The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 6 months post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | 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 | 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 | 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 | 6 months | The smallest lumen diameter in the segment of interest |
| Device success | 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). |
| Angiographic outcomes: Restenosis rate | 6 months | Restenosis is defined as ≥50% diameter stenosis at follow-up. |
| Device oriented Composite Endpoint (DoCE / TLF): Cardiac death | 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) | 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) | 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. |
| Angiographic outcomes: Percent diameter stenosis | 6 months | The percentage of luminal narrowing of vessel segment of interest |
Countries
Ireland, Italy, United Kingdom
Outcome results
None listed