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

Conditions: Coronary Artery Disease

Sex: All

Enrollment: 500

Sponsor: Istituto Clinico Sant'Ambrogio

Location: Italy

Summary

An observational study to evaluate safety and efficacy of the hybrid approach DES/DCB in the treatment of long diffuse de novo coronary artery disease

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 FormExclusion 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 monthsSevere calcification or/tortuosity proximally or at the DCB target segment;Prior PCI and stent implantation in the target vessel.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05650450). StuddyBuddy aggregates publicly available trial information.