Clinical trial NCT06373601: SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective
Official title: Selution Sirolimus Coated Balloon (MedAlliance) Versus SeQuent Please Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Medium-small Size Vessels.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Stenosis Coronary
Coronary Artery Lesion
Percutaneous Coronary Intervention
Lead sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 exclusion criteria:
15. Target vessel size \>3.00 mm
16. Target vessel size ≤2.00 mm
17. Target lesion has a diameter stenosis \< 50% prior to pre-dilatation
18. Target lesion has a total occlusion or TIMI flow \< 2 prior to pre-dilatation
19. Pre-dilatation of the target lesion not performed or not successful (residual stenosis \> 30%, TIMI flow \< 3 and presence of major angiographic dissections)
20. Target lesion in left main stem
21. The target vessel contains visible thrombus
22. Aorto-ostial target lesion (within 3 mm of the aorta junction)
23. Lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft

Primary outcomes:
measure: In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure
timeFrame: 12 months post-procedure
measure: Fractional Flow Reserve (FFR)
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
measure: Device success (lesion based)
timeFrame: 12 months post-procedure
measure: Procedure success
timeFrame: 12 months post-procedure
measure: Angiographic outcomes 1
timeFrame: 12 months post-procedure
measure: Angiographic outcomes 2
timeFrame: 12 months post-procedure
measure: Angiographic outcomes 3
timeFrame: 12 months post-procedure
measure: Angiographic outcomes 4
timeFrame: 12 months post-procedure
measure: Device oriented Composite Endpoint (DoCE/ TLF)
timeFrame: 12 months post-procedure
measure: Acute/subacute/early/late vessel thrombosis
timeFrame: 12 months post-procedure
measure: Periprocedural myocardial infarction
timeFrame: From enrollment to the end of treatment at 12 months
measure: PCI related myocardial injury
timeFrame: From enrollment to the end of treatment at 12 months
measure: Absolute difference in CFR for the first 100 patients treated with DCB ≥ 30 mm
timeFrame: baseline
measure: Absolute variation in IMR for the first 100 patients treated with DCB ≥ 30 mm
timeFrame: baseline
measure: Absolute decrease in CFR for the first 100 patients treated with DCB ≥ 30 mm
timeFrame: baseline
Other outcomes:
Locations:
city: Mercogliano
country: Italy
facility: Clinica Montevergine
state: Italy/Avellino
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
state: Italy/Bergamo
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
state: Italy/Brescia
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
state: Italy/Ferrara
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
state: Italy/Milano
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Italy/Milano
city: Napoli
country: Italy
facility: Clinica Mediterranea
state: Italy/Napoli
city: Orbassano
country: Italy
facility: Azienda Ospedaliero Universitaria San Luigi Gonzaga
state: Italy/Torino
city: Rivoli
country: Italy
facility: Ospedale di Rivoli
state: Italy/Torino
city: Vercelli
country: Italy
facility: Ospedale Sant'Andrea
state: Italy/Vercelli
Study officials:
affiliation: Fondazione Evidence ONLUS
name: Antonio AC Colombo, MD
role: STUDY_CHAIR
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