SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective
Italy140 participantsStarted 2024-09-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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)
✕. 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
What they're measuring
1
In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure
Timeframe: 12 months post-procedure
2
Fractional Flow Reserve (FFR)
Timeframe: From enrollment to the end of treatment at 12 months
Trial details
NCT IDNCT06373601
SponsorFondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
. 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 suffered from stroke/TIA during the last 6 months
✕. 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)