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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Invitation-only

Conditions: Coronary Artery Disease

Treatments: Device: DES+DCB

Study type: Observational

Funder types: Other

Identifiers

NCT05650450

HYPER II

Details and patient eligibility

About

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

Full description

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 diffuse CAD -avoiding a long metallic, permanent cage within extended coronary segments

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)

Treatment:

Device: DES+DCB