SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective

Coronary Artery Disease Clinical Trial

— SPAGO  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373601
• Other study ID #: SPAGO
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2024
• Source: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
• Contact: Marina Cornacchia Schenetti
• Phone: 03761810406
• Email: schema1950[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) at 12 months follow-up.

Description:

This is a prospective, randomized, multicenter, no-profit and post-market study in subjects with small vessels, i.e. at least one de novo lesion in a small vessel (>2.00 mm and ≤3.00). Vessel size is evaluated by visual estimation. It is possible to include more than one study lesion even if they are located in the same vessel. In case of a successful pre-dilatation (i.e. no major (type D, E, F) angiographic dissections, residual stenosis ≤ 30% and TIMI flow ≥ 2), the subject will be randomized in a 1:1 fashion to Selution or SeQuent Please Neo. If the Investigator decides to include more than one study lesion for the same subject, all the lesions must be successful pre-dilatated and must be treated following the assigned treatment by randomization. Other not study lesions (if applicable) can be treated with any other commercial device (e.g. drug-eluting stent). All not study lesions should be treated prior to study target lesion procedure, and should be successful and uncomplicated. Follow-up by phone call will occur at 1 and 6 months post-PCI. At 12 months all subjects will perform an angiographic follow up at the same site where the index procedure was performed. Quantitative Coronary Angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and on follow up angiography by the imaging core lab. All subjects must receive dual anti-platelet therapy (DAPT), being aspirin (ASA) and P2Y12 inhibition therapy for at least 1 month after drug coated balloon PCI or according to standard local practice (with the choice of agent left to the discretion of the investigator), followed by ASA monotherapy indefinitely. However, in case the subject had recent ACS or is receiving additional drug-eluting stents, DAPT must be given according to local standard of care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 = 50% (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. Target lesion length =35 mm

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Lesion
• Coronary Stenosis
• Percutaneous Coronary Intervention

Intervention

Device:
• sirolimus-eluting balloon (Selution)
PCI treatment with DCB, in particular sirolimus coated balloon
• paclitaxel-eluting balloon (SeQuent Please Neo)
PCI treatment with DCB, in particular paclitaxel coated balloon

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure	The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure. Net Gain is defined as acute gain at the time of the index procedure minus late loss at the time of follow-up angiography.	12 months post-procedure
Secondary	Device success (lesion based)	Successful delivery and inflation within 45 seconds of the allocated DCB device at the intended target lesion during an attempt with a DCB not previously used (first use) and successful withdrawal of the device system with attainment of final in-lesion residual stenosis of <30%. I	12 months post-procedure
Secondary	Procedure success	Successful delivery and inflation within 45 seconds of the allocated DCB device at the intended target lesion during an attempt with a DCB not previously used (first use) and successful withdrawal of the device system with attainment of final in-lesion residual stenosis of <30 % without the occurrence of TLF during the index procedure hospital stay).	12 months post-procedure
Secondary	Angiographic outcomes 1	late lumen loss	12 months post-procedure
Secondary	Angiographic outcomes 2	minimal lumen diameter	12 months post-procedure
Secondary	Angiographic outcomes 3	percent diameter stenosis	12 months post-procedure
Secondary	Angiographic outcomes 4	restenosis rate	12 months post-procedure
Secondary	Device oriented Composite Endpoint (DoCE/ TLF)	DoCE/ TLF which is composite of cardiac death, TV-MI, and clinically indicated target lesion revascularization (TLR)	12 months post-procedure
Secondary	Acute/subacute/early/late vessel thrombosis	Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the patient left the catheterization lab.	12 months post-procedure

External Links

•   Non-Inferiority Clinical Trials
•   SELUTION SLR™ 014 In-stent Restenosis