Actively Recruiting
SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective
Led by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS · Updated on 2025-12-03
140
Participants Needed
10
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects 18 years or older
- Chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values
- At least one de novo lesion in a small vessel (>2.00 mm and 3.00 mm) with 50% to 99% diameter stenosis before predilatation
- Target lesion to be treated with drug-coated balloon shorter than 30 mm (up to 40 patients) or 30 mm or longer (at least 100 patients)
- Able to understand, provide informed consent, and comply with study procedures including 12 months angiographic follow-up
- Completed follow-up phase of any previous study
You will not qualify if you...
- Pregnant or nursing women (pregnancy test required within 7 days before procedure for women of child-bearing potential)
- Ongoing acute myocardial infarction or elevated cardiac biomarkers not normalized at time of procedure
- Known allergy or contraindication to sirolimus, paclitaxel, aspirin, heparin, clopidogrel bisulfate, ticlopidine, prasugrel, or ticagrelor
- Previous drug-coated balloon PCI in target epicardial territory within last 12 months
- Stroke or transient ischemic attack in last 6 months
- Left ventricular ejection fraction below 30%
- Platelet count below 100,000 or above 400,000 cells/mm3, white blood cell count below 3,000 cells/mm3, or liver disease including hepatitis
- Renal insufficiency (serum creatinine >2.5 mg/dL, creatinine clearance 30 mL/min, eGFR 30 mL/min/m2), dialysis, or acute kidney failure
- Planned surgery within 1 month requiring stopping dual anti-platelet therapy
- History of bleeding disorders or coagulopathy
- Heart transplant recipient
- Life expectancy less than 12 months due to other medical conditions
- Unable or unwilling to return for 12 months follow-up angiographic procedure
- Currently participating in another clinical trial
- Target vessel size outside 2.00 mm to 3.00 mm range
- Target lesion diameter stenosis less than 50% before predilatation
- Target lesion total occlusion or TIMI flow less than 2 before predilatation
- Unsuccessful or no predilatation of target lesion
- Target lesion in left main stem
- Visible thrombus in target vessel
- Aorto-ostial target lesion (within 3 mm of aorta junction)
- Lesion located in or distal to arterial or saphenous vein grafts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Clinica Montevergine
Mercogliano, Italy/Avellino, Italy, 83013
Actively Recruiting
2
ASST Papa Giovanni XXIII
Bergamo, Italy/Bergamo, Italy, 24127
Actively Recruiting
3
Fondazione Poliambulanza
Brescia, Italy/Brescia, Italy, 25124
Actively Recruiting
4
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Italy/Ferrara, Italy, 44124
Withdrawn
5
Centro Cardiologico Monzino
Milan, Italy/Milano, Italy, 20138
Actively Recruiting
6
Istituto Clinico Humanitas
Rozzano, Italy/Milano, Italy, 20089
Actively Recruiting
7
Clinica Mediterranea
Naples, Italy/Napoli, Italy, 80122
Actively Recruiting
8
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano, Italy/Torino, Italy, 10043
Actively Recruiting
9
Ospedale di Rivoli
Rivoli, Italy/Torino, Italy, 10098ù
Actively Recruiting
10
Ospedale Sant'Andrea
Vercelli, Italy/Vercelli, Italy, 13100
Not Yet Recruiting
Research Team
M
Marina MCS Cornacchia Schenetti
CONTACT
R
Riccardo RF Falzone
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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