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SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective

NCT06373601 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-12-03

No results posted yet for this study

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

Interventions

DEVICE

sirolimus-eluting balloon (Selution)

PCI treatment with DCB, in particular sirolimus coated balloon

DEVICE

paclitaxel-eluting balloon (SeQuent Please Neo)

PCI treatment with DCB, in particular paclitaxel coated balloon

Sponsors & Collaborators

  • Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

    lead OTHER

Principal Investigators

  • Antonio AC Colombo, MD · Fondazione Evidence ONLUS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-05
Primary Completion
2027-08-01
Completion
2027-08-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06373601 on ClinicalTrials.gov