SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective

NCT06373601 | Recruiting

• 1 other identifier: SPAGO
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Coronary Artery Disease; Stenosis Coronary; Coronary Artery Lesion; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

• 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

• Fractional Flow Reserve (FFR)

  FFR (absolute value) at 12 months post-procedure

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (13)

• Device success (lesion based)

  12 months post-procedure

• Procedure success

  12 months post-procedure

• Angiographic outcomes 1

  12 months post-procedure

• Angiographic outcomes 2

  12 months post-procedure

• Angiographic outcomes 3

  12 months post-procedure

Study Arms (2)

sirolimus-eluting balloon (Selution)

EXPERIMENTAL

DCB angioplasty with a sirolimus-eluting balloon

Device: sirolimus-eluting balloon (Selution)

paclitaxel-eluting balloon (SeQuent Please Neo)

ACTIVE COMPARATOR

DCB angioplasty with a paclitaxel-eluting balloon

Device: paclitaxel-eluting balloon (SeQuent Please Neo)

Interventions

sirolimus-eluting balloon (Selution) DEVICE

PCI treatment with DCB, in particular sirolimus coated balloon

sirolimus-eluting balloon (Selution)

paclitaxel-eluting balloon (SeQuent Please Neo) DEVICE

PCI treatment with DCB, in particular paclitaxel coated balloon

paclitaxel-eluting balloon (SeQuent Please Neo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• Subject undergoing planned surgery within 1 month with the necessity to stop DAPT
• History of bleeding diathesis or coagulopathy
• The subject is a recipient of a heart transplant
• Concurrent medical condition with a life expectancy of less than 12 months
• The subject is unwilling/not able to return for angiographic re-catheterisation at 12 months follow-up
• Currently participating in another trial
• Target vessel size \>3.00 mm

Sponsors & Collaborators

• Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS: lead

Study Sites (10)

Clinica Montevergine

Mercogliano, Italy/Avellino, 83013, Italy

RECRUITING

ASST Papa Giovanni XXIII

Bergamo, Italy/Bergamo, 24127, Italy

RECRUITING

Fondazione Poliambulanza

Brescia, Italy/Brescia, 25124, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Italy/Ferrara, 44124, Italy

WITHDRAWN

Centro Cardiologico Monzino

Milan, Italy/Milano, 20138, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, Italy/Milano, 20089, Italy

RECRUITING

Clinica Mediterranea

Naples, Italy/Napoli, 80122, Italy

RECRUITING

Azienda Ospedaliero Universitaria San Luigi Gonzaga

Orbassano, Italy/Torino, 10043, Italy

RECRUITING

Ospedale di Rivoli

Rivoli, Italy/Torino, 10098ù, Italy

RECRUITING

Ospedale Sant'Andrea

Vercelli, Italy/Vercelli, 13100, Italy

NOT YET RECRUITING

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Related Links

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

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Antonio AC Colombo, MD

  Fondazione Evidence ONLUS

  STUDY CHAIR

Central Study Contacts

Marina MCS Cornacchia Schenetti

CONTACT

03761810406; schema1950@gmail.com

Riccardo RF Falzone

CONTACT

spagostudy@we4cr.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 140 subjects will be enrolled in a competitive way and 1:1 randomized to receive treatment with either the study device (SelutionTM) or the control device (SeQuent Please NeoTM). Randomization will be stratified according to DCB length: at least 100 patients treated with DCB ≥ 30 mm will be assigned to either SelutionTM or SeQuent Please NeoTM, while a maximum of 40 patients treated with DCB \< 30 mm will be assigned to either SelutionTM or SeQuent Please NeoTM. A minimum of 100 subjects treated with DCB ≥ 30 mm is considered necessary to provide an initial evaluation of intramyocardial resistance measurements, due to the lack of literature data on these parameters.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 18, 2024
• Study Start: September 5, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

IT (10)