Coronary Artery Disease, Coronary Artery Lesion, Percutaneous Coronary Intervention, Stenosis Coronary
Conditions
Brief summary
The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (\>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) and Fractional Flow Reserve (FFR) at 12 months follow-up.
Detailed description
This is a prospective, randomized, multicenter, no-profit and post-market study in subjects with small vessels, i.e. at least one de novo lesion in a small vessel (\>2.00 mm and ≤3.00). Vessel size is evaluated by visual estimation. It is possible to include only one study lesion per patient. For the purposes of this study, in cases of diffuse coronary artery disease where overlapped DCB are utilized for the treatment of the lesion, this will be considered as a single lesion. In case of a successful predilatation (i.e. no major (type D, E, F) angiographic dissections, residual stenosis ≤ 30% and TIMI flow = 3), the subject will be randomized in a 1:1 fashion to SelutionTM or SeQuent Please NeoTM. Randomization will be stratified according to DCB length (\< 30 mm or ≥ 30 mm) in order to include at least 100 patients treated with DCB of 30 mm or longer. Measurements of intramyocardial resistances, after lesion preparation prior to DCB treatment and after DCB treatment (2 measurements), will be limited to a maximum of 100 lesions treated with DCB ≥ 30 mm. Given the lack of literature data on intramyocardial resistance measurements, a minimum of 100 subjects is considered necessary to provide an initial evaluation of these parameters. With a total sample size of 140 patients for the study, it will be allowed to enroll up to 40 patients treated with DCB \< 30 mm. Once this limit is reached, only patients treated with DCB ≥ 30 mm will be enrolled while maintaining a 1:1 randomization ratio. During the index procedure, it is possible to treat other not study lesions (if applicable) with any other commercial device (e.g. drug-eluting stent) if they are located in a different epicardial territory than the study target lesion. All not studylesions should be treated prior to study target lesion procedure, and should be successful and uncomplicated. Follow-up by phone call will occur at 1 and 6 months post-PCI. At 12 months all subjects will perform an angiographic follow up at the same site where the index procedure was performed. Quantitative Coronary Angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and on follow up angiography by the imaging core lab. FFR assessment will be performed at the time of follow-up angiography. All subjects must receive dual anti-platelet therapy (DAPT), being aspirin (ASA) and P2Y12 inhibition therapy for at least 1 month after drug coated balloon PCI or according to standard local practice (with the choice of agent left to the discretion of the investigator), followed by ASA monotherapy indefinitely. However, in case the subject had recent ACS or is receiving additional drug-eluting stents, DAPT must be given according to local standard of care.
Interventions
DEVICEsirolimus-eluting balloon (Selution)
PCI treatment with DCB, in particular sirolimus coated balloon
DEVICEpaclitaxel-eluting balloon (SeQuent Please Neo)
PCI treatment with DCB, in particular paclitaxel coated balloon
Sponsors
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
140 subjects will be enrolled in a competitive way and 1:1 randomized to receive treatment with either the study device (SelutionTM) or the control device (SeQuent Please NeoTM). Randomization will be stratified according to DCB length: at least 100 patients treated with DCB ≥ 30 mm will be assigned to either SelutionTM or SeQuent Please NeoTM, while a maximum of 40 patients treated with DCB \< 30 mm will be assigned to either SelutionTM or SeQuent Please NeoTM. A minimum of 100 subjects treated with DCB ≥ 30 mm is considered necessary to provide an initial evaluation of intramyocardial resistance measurements, due to the lack of literature data on these parameters.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects ≥18 years 2. Subject with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values. 3. The subject has at least one de-novo lesion in a small vessel (\>2.00 mm and ≤3.00 mm prior to pre-dilatation) with a diameter stenosis between 50% and 99% (prior to pre-dilatation). It is possible to enroll subjects that have a stent previously implanted in the same epicardial territory (main vessel and ramifications) of the target lesion 4. Patients with target lesion to be treated with DCB \< 30 mm in length (up to 40 patients) or with DCB ≥ 30 mm in length (at least 100 patients) 5. Able to understand and provide informed consent and comply with all study procedures including 12 months angiographic follow-up 6. Subject must have completed the follow-up phase of any previous study
Exclusion criteria
1. Subject 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. Subjects who experienced a previous PCI with DCB in the epicardial territory (main vessel and ramifications) where the target lesion is located, during the last 12 months 5. Subject suffered from stroke/TIA during the last 6 months 6. LVEF \<30% 7. 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) 8. Known renal insufficiency (e.g. serum creatinine \>2,5 mg/dL, creatinine clearance ≤30 mL/min or eGFR ≤30 mL/min/m2), or subject on dialysis, or acute kidney failure (as per physician judgment) 9. Subject undergoing planned surgery within 1 month with the necessity to stop DAPT 10. History of bleeding diathesis or coagulopathy 11. The subject is a recipient of a heart transplant 12. Concurrent medical condition with a life expectancy of less than 12 months 13. The subject is unwilling/not able to return for angiographic re-catheterisation at 12 months follow-up 14. Currently participating in another trial Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure | 12 months post-procedure | The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure. Net Gain is defined as acute gain at the time of the index procedure minus late loss at the time of follow-up angiography. |
| Fractional Flow Reserve (FFR) | From enrollment to the end of treatment at 12 months | FFR (absolute value) at 12 months post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic outcomes 1 | 12 months post-procedure | late lumen loss |
| Angiographic outcomes 2 | 12 months post-procedure | minimal lumen diameter |
| Angiographic outcomes 3 | 12 months post-procedure | percent diameter stenosis |
| Angiographic outcomes 4 | 12 months post-procedure | restenosis rate |
| Device oriented Composite Endpoint (DoCE/ TLF) | 12 months post-procedure | DoCE/ TLF which is composite of cardiac death, TV-MI, and clinically indicated target lesion revascularization (TLR) |
| Device success (lesion based) | 12 months post-procedure | 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%. I |
| Periprocedural myocardial infarction | From enrollment to the end of treatment at 12 months | Periprocedural myocardial infarction according to the Fourth Universal definition of Myocardial Infarction |
| PCI related myocardial injury | From enrollment to the end of treatment at 12 months | PCI related myocardial injury, defined according to the Fourth Universal definition of Myocardial Infarction estimating the absolute value of troponin pre-discharge or within 3-8 hours post-PCI |
| Absolute difference in CFR for the first 100 patients treated with DCB ≥ 30 mm | baseline | Absolute difference in CFR measured with a dedicated system (PressureWire™ X Guidewire and Coroventis CoroFlow Cardiovascular System, Abbott) |
| Absolute variation in IMR for the first 100 patients treated with DCB ≥ 30 mm | baseline | Absolute variation in IMR from the first assessment (after predilation) to the second assessment (after DCB angioplasty) |
| Absolute decrease in CFR for the first 100 patients treated with DCB ≥ 30 mm | baseline | Absolute decrease in CFR from the first assessment (after predilatation) to the second assessment (after DCB angioplasty) |
| Acute/subacute/early/late vessel thrombosis | 12 months post-procedure | Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the patient left the catheterization lab. |
| Procedure success | 12 months post-procedure | 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 % without the occurrence of TLF during the index procedure hospital stay). |
Countries
Italy
Contacts
Primary ContactMarina MCS Cornacchia Schenetti
Backup ContactRiccardo RF Falzone
Outcome results
None listed