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Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent

NCT05516446 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2022-08-25

No results posted yet for this study

Summary

Randomized, open-label, single-center, non-inferiority clinical trial to compare late lumen loss (LLL) at 12 months in Tunisian population undergoing coronary percutaneous intervention between Drug Eluting Balloon treated group and Everolimus platinum chrome stent treated group.

Conditions

  • Percutaneous Coronary Intervention (PCI)
  • Coronary Artery Disease (CAD)
  • De Novo Stenosis

Interventions

DEVICE

DEB for de Novo Lesions

The surface of the SeQuent® Please NEO balloon is coated with Paclitaxel at a concentration of 3 μg Paclitaxel per mm² of balloon surface. The matrix composed of Paclitaxel and Iopromide (Paccocath technology) allows homogeneous release of the active ingredient through the vessel surface.

DEVICE

DES for de Novo Lesions

The latest generation DES : everolimus-eluting platinum-chromium alloy coronary stent system (Promus Premier, Promus Elite)

Sponsors & Collaborators

  • B. Braun Medical International Trading Company Ltd.

    collaborator INDUSTRY

  • General Administration of Military Health, Tunisia

    lead NETWORK

Principal Investigators

  • Aymen Noamen, MD · military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis

  • Nadhem Hajlaoui, Pr · military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis

  • Wafa Fehri, Pr · military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-25
Primary Completion
2022-11-30
Completion
2022-12-31

Countries

  • Tunisia

Study Locations

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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 NCT05516446 on ClinicalTrials.gov