Compares two balloon devices for narrowed heart arteries in adults
Compares two drug-coated balloons used to open narrowed coronary arteries in adults.
Plain-language title generated from the registry record
Registry title: SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective
Key facts
- Where
- Bergamo, Brescia, Ferrara, Mercogliano, Milan, Naples, Orbassano, Rivoli, Rozzano, and Vercelli, ItalySee the 10 sites
Where in Italy
- Asst Papa Giovanni XXIIIBergamo, ItalyTaking people
- Fondazione PoliambulanzaBrescia, ItalyTaking people
- Azienda Ospedaliero Universitaria di FerraraFerrara, ItalyNo longer taking part
- Clinica MontevergineMercogliano, ItalyTaking people
- Centro Cardiologico MonzinoMilan, ItalyTaking people
- Clinica MediterraneaNaples, ItalyTaking people
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
- Ospedale di RivoliRivoli, ItalyTaking people
- Istituto Clinico HumanitasRozzano, ItalyTaking people
- Ospedale Sant'AndreaVercelli, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
- Trial code
- NCT06373601
- Record updated
- 3 December 2025
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: Male or female subjects ≥18 years; Subject with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values; 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; 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); Able to understand and provide informed consent and comply with all study procedures including 12 months angiographic follow-up; Subject must have completed the follow-up phase of any previous study.
Exclusion: 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); 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; Subject undergoing planned surgery within 1 month with the necessity to stop DAPT; Concurrent medical condition with a life expectancy of less than 12 months; Target lesion has a diameter stenosis < 50% prior to pre-dilatation; Target lesion has a total occlusion or TIMI flow < 2 prior to pre-dilatation; 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; 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; Subject suffered from stroke/TIA during the last 6 months; History of bleeding diathesis or coagulopathy; The subject is a recipient of a heart transplant; LVEF <30%; 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); 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); The subject is unwilling/not able to return for angiographic re-catheterisation at 12 months follow-up; Currently participating in another trial; Angiographic exclusion criteria:; Target vessel size >3.00 mm; Target vessel size ≤2.00 mm; Pre-dilatation of the target lesion not performed or not successful (residual stenosis > 30%, TIMI flow < 3 and presence of major angiographic dissections); Target lesion in left main stem; The target vessel contains visible thrombus; Aorto-ostial target lesion (within 3 mm of the aorta junction); Lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft.