SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective (SPAGO)

November 25, 2025 updated by: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 only one study lesion per patient. For the purposes of this study, in cases of diffuse coronary artery disease where overlapped DCB are utilized for the treatment of the lesion, this will be considered as a single lesion. In case of a successful predilatation (i.e. no major (type D, E, F) angiographic dissections, residual stenosis ≤ 30% and TIMI flow = 3), the subject will be randomized in a 1:1 fashion to SelutionTM or SeQuent Please NeoTM. Randomization will be stratified according to DCB length (< 30 mm or ≥ 30 mm) in order to include at least 100 patients treated with DCB of 30 mm or longer. Measurements of intramyocardial resistances, after lesion preparation prior to DCB treatment and after DCB treatment (2 measurements), will be limited to a maximum of 100 lesions treated with DCB ≥ 30 mm. Given the lack of literature data on intramyocardial resistance measurements, a minimum of 100 subjects is considered necessary to provide an initial evaluation of these parameters. With a total sample size of 140 patients for the study, it will be allowed to enroll up to 40 patients treated with DCB < 30 mm. Once this limit is reached, only patients treated with DCB ≥ 30 mm will be enrolled while maintaining a 1:1 randomization ratio. During the index procedure, it is possible to treat other not study lesions (if applicable) with any other commercial device (e.g. drug-eluting stent) if they are located in a different epicardial territory than the study target lesion. All not studylesions 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. FFR assessment will be performed at the time of follow-up angiography.

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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Italy/Avellino
      • Mercogliano, Italy/Avellino, Italy, 83013
        • Recruiting
        • Clinica Montevergine
        • Contact:
    • Italy/Bergamo
      • Bergamo, Italy/Bergamo, Italy, 24127
        • Recruiting
        • Asst Papa Giovanni Xxiii
        • Contact:
    • Italy/Brescia
      • Brescia, Italy/Brescia, Italy, 25124
    • Italy/Ferrara
      • Ferrara, Italy/Ferrara, Italy, 44124
        • Withdrawn
        • Azienda Ospedaliero Universitaria di Ferrara
    • Italy/Milano
      • Milan, Italy/Milano, Italy, 20138
      • Rozzano, Italy/Milano, Italy, 20089
    • Italy/Napoli
      • Napoli, Italy/Napoli, Italy, 80122
    • Italy/Torino
      • Orbassano, Italy/Torino, Italy, 10043
        • Recruiting
        • Azienda Ospedaliero Universitaria San Luigi Gonzaga
        • Contact:
      • Rivoli, Italy/Torino, Italy, 10098ù
        • Recruiting
        • Ospedale di Rivoli
        • Contact:
        • Sub-Investigator:
          • Ferdinando Varbella, MD
    • Italy/Vercelli
      • Vercelli, Italy/Vercelli, Italy, 13100
        • Not yet recruiting
        • Ospedale Sant'Andrea
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sirolimus-eluting balloon (Selution)
DCB angioplasty with a sirolimus-eluting balloon
Device: sirolimus-eluting balloon (Selution)
PCI treatment with DCB, in particular sirolimus coated balloon
Active Comparator: paclitaxel-eluting balloon (SeQuent Please Neo)
DCB angioplasty with a paclitaxel-eluting balloon
Device: paclitaxel-eluting balloon (SeQuent Please Neo)
PCI treatment with DCB, in particular paclitaxel coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure
Time Frame: 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
Fractional Flow Reserve (FFR)
Time Frame: From enrollment to the end of treatment at 12 months
FFR (absolute value) at 12 months post-procedure
From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device success (lesion based)
Time Frame: 12 months post-procedure
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
Procedure success
Time Frame: 12 months post-procedure
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
Angiographic outcomes 1
Time Frame: 12 months post-procedure
late lumen loss
12 months post-procedure
Angiographic outcomes 2
Time Frame: 12 months post-procedure
minimal lumen diameter
12 months post-procedure
Angiographic outcomes 3
Time Frame: 12 months post-procedure
percent diameter stenosis
12 months post-procedure
Angiographic outcomes 4
Time Frame: 12 months post-procedure
restenosis rate
12 months post-procedure
Device oriented Composite Endpoint (DoCE/ TLF)
Time Frame: 12 months post-procedure
DoCE/ TLF which is composite of cardiac death, TV-MI, and clinically indicated target lesion revascularization (TLR)
12 months post-procedure
Acute/subacute/early/late vessel thrombosis
Time Frame: 12 months post-procedure
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
Periprocedural myocardial infarction
Time Frame: From enrollment to the end of treatment at 12 months
Periprocedural myocardial infarction according to the Fourth Universal definition of Myocardial Infarction
From enrollment to the end of treatment at 12 months
PCI related myocardial injury
Time Frame: From enrollment to the end of treatment at 12 months
PCI related myocardial injury, defined according to the Fourth Universal definition of Myocardial Infarction estimating the absolute value of troponin pre-discharge or within 3-8 hours post-PCI
From enrollment to the end of treatment at 12 months
Absolute difference in CFR for the first 100 patients treated with DCB ≥ 30 mm
Time Frame: baseline
Absolute difference in CFR measured with a dedicated system (PressureWire™ X Guidewire and Coroventis CoroFlow Cardiovascular System, Abbott)
baseline
Absolute variation in IMR for the first 100 patients treated with DCB ≥ 30 mm
Time Frame: baseline
Absolute variation in IMR from the first assessment (after predilation) to the second assessment (after DCB angioplasty)
baseline
Absolute decrease in CFR for the first 100 patients treated with DCB ≥ 30 mm
Time Frame: baseline
Absolute decrease in CFR from the first assessment (after predilatation) to the second assessment (after DCB angioplasty)
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

Investigators

  • Study Chair: Antonio AC Colombo, MD, Fondazione Evidence ONLUS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPAGO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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