Sirolimus versus paclitaxel coated balloon for small coronary artery lesions
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.
This compares a sirolimus-coated balloon and a paclitaxel-coated balloon to see which keeps medium-size coronary arteries (2.00–3.00 mm) more open and improves blood flow at 12 months in adults with new coronary lesions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS Academic / other |
| Locations | 10 sites (Mercogliano, Italy/Avellino and 9 other locations) |
| Trial ID | NCT06373601 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, multicenter, post‑market, no‑profit trial enrolling adults with a single de novo lesion in a small coronary vessel (2.00–3.00 mm). After successful lesion preparation, subjects are randomized 1:1 to treatment with either a Selution sirolimus‑coated balloon or a SeQuent Please Neo paclitaxel‑coated balloon, with stratification by balloon length (<30 mm vs ≥30 mm). Primary angiographic outcomes are Net Gain (mm) and fractional flow reserve (FFR) at 12 months, and a subset of up to 100 longer lesions will have intramyocardial resistance measured. The protocol targets about 140 patients total, permits only one study lesion per patient, and prioritizes enrollment of at least 100 patients treated with balloons ≥30 mm.
Who should consider this trial
Good fit: Adults (≥18 years) with chronic stable angina or stabilized acute coronary syndrome who have a single de novo lesion in a small coronary vessel (2.00–3.00 mm) suitable for drug‑coated balloon treatment and who can complete 12‑month angiographic follow‑up.
Not a fit: Patients with larger vessels (>3.00 mm), lesions that require stenting or have major angiographic dissections after predilatation, pregnant or nursing women, or those unable to complete follow‑up are unlikely to be appropriate or to benefit from participation.
Why it matters
Potential benefit: If successful, the results could show which drug‑coated balloon produces greater lumen gain and better functional blood flow in small coronary arteries, helping clinicians choose devices and potentially reducing the need for stenting.
How similar studies have performed: Paclitaxel‑coated balloon angioplasty has established evidence for small coronary vessels, while sirolimus‑coated balloons are a newer option with encouraging but less mature clinical data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mercogliano, Italy/Avellino and 9 other locations
- Clinica Montevergine — Mercogliano, Italy/Avellino, Italy (Recruiting)
- ASST Papa Giovanni XXIII — Bergamo, Italy/Bergamo, Italy (Recruiting)
- Fondazione Poliambulanza — Brescia, Italy/Brescia, Italy (Recruiting)
- Azienda Ospedaliero Universitaria di Ferrara — Ferrara, Italy/Ferrara, Italy (Withdrawn)
- Centro Cardiologico Monzino — Milan, Italy/Milano, Italy (Recruiting)
- Istituto Clinico Humanitas — Rozzano, Italy/Milano, Italy (Recruiting)
- Clinica Mediterranea — Naples, Italy/Napoli, Italy (Recruiting)
- Azienda Ospedaliero Universitaria San Luigi Gonzaga — Orbassano, Italy/Torino, Italy (Recruiting)
- Ospedale di Rivoli — Rivoli, Italy/Torino, Italy (Recruiting)
- Ospedale Sant'Andrea — Vercelli, Italy/Vercelli, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Marina MCS Cornacchia Schenetti
- Email: schema1950@gmail.com
- Phone: 03761810406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.