Trials
Search / Trial NCT05650450

Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease

Launched by I.R.C.C.S OSPEDALE GALEAZZI-SANT'AMBROGIO · Dec 4, 2022

Trial Information

Current as of February 05, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This is a prospective, non-randomized, single-arm, multi-center study aiming to assess the feasibility and the clinical outcomes of using the Restore DCB (Cardionovum GmbH, Bonn, Germany) in combination ("hybrid approach") with a new generation DES (type at operator's discretion) for the treatment of diffuse CAD (Coronary Artery Disease) encountered in daily clinical practice (lesion length \> 38 mm). The rationale of the proposed strategy derives from the characteristics of DCB in treating the atherosclerotic disease without leaving a permanent structure in the vessel especially in case of...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (\>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD\>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment);
  • Signed Patient Informed Consent/Data Release Form
  • Exclusion Criteria:
  • Age \<18 years;
  • Cardiogenic shock;
  • Pregnancy or breastfeeding;
  • Target vessel reference diameter (within planned device deployment segments) \<2.0 or \>5.0 mm;
  • Comorbidities with life expectancy \<12 months
  • Severe calcification or/tortuosity proximally or at the DCB target segment;
  • Prior PCI and stent implantation in the target vessel.

About I.R.C.C.S Ospedale Galeazzi Sant'ambrogio

The I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio is a leading clinical research institute and hospital in Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As a designated Institute of Hospitalization and Care of Scientific Relevance (I.R.C.C.S.), it focuses on translational research that bridges the gap between laboratory findings and clinical applications. The facility is equipped with state-of-the-art technology and a multidisciplinary team of experts, enabling it to conduct a wide range of clinical trials aimed at improving treatment outcomes across various medical fields. Its dedication to ethical practices and patient safety ensures that all research activities align with the highest international standards.

Locations

Milano, , Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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