Sirolimus versus paclitaxel coated balloon for small coronary artery lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinica Montevergine
  Mercogliano, Italy/Avellino, Italy Recruiting
• ASST Papa Giovanni XXIII
  Bergamo, Italy/Bergamo, Italy Recruiting
• Fondazione Poliambulanza
  Brescia, Italy/Brescia, Italy Recruiting
• Centro Cardiologico Monzino
  Milan, Italy/Milano, Italy Recruiting
• Istituto Clinico Humanitas
  Rozzano, Italy/Milano, Italy Recruiting
• Clinica Mediterranea
  Naples, Italy/Napoli, Italy Recruiting

Study contacts

• Study coordinator: Marina MCS Cornacchia Schenetti
• Email: schema1950@gmail.com
• Phone: 03761810406

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.