NCT06373601 SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective
| NCT ID | NCT06373601 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-09-05 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2024-09-05 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Antonio AC Colombo, MD
STUDY CHAIR
Fondazione Evidence ONLUS
Frequently Asked Questions
Who can join the NCT06373601 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06373601 currently recruiting?
Yes, NCT06373601 is actively recruiting participants. Contact the research team at schema1950@gmail.com for enrollment information.
Where is the NCT06373601 trial being conducted?
This trial is being conducted at Mercogliano, Italy, Bergamo, Italy, Brescia, Italy, Ferrara, Italy and 6 additional locations.
Who is sponsoring the NCT06373601 clinical trial?
NCT06373601 is sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS. The principal investigator is Antonio AC Colombo, MD at Fondazione Evidence ONLUS. The trial plans to enroll 140 participants.