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

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.