Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent for de Novo Diffuse Disease Treatment (HYPER)

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

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: DES+DCB

Study type: Observational

Funder types: Other

Identifiers

NCT03939468

HYPER v3

Details and patient eligibility

About

A Pilot Observational Study to evaluate safety and efficacy of the hybrid approach DES/DCB in treating de-novo diffuse lesions

Full description

This is a prospective, non-randomized, single-arm, multi-center, pilot, noninterventional study whose aim is 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 encountered in daily clinical practice. 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: 106 patients

Sex: All

Ages: 18+ 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 CAD involving segments suitable for a hybrid approach;
• Signed Patient Informed Consent/Data Release Form

Exclusion criteria

1. Age <18 years;
2. Cardiogenic shock;
3. Pregnancy or breastfeeding;
4. Infarct-artery max diameter (within planned device deployment segment) <2.0 or >5.0 mm;
5. Comorbidities with life expectancy <6 months;
6. Severe calcification or/tortuosity proximally or at the DCB target segment;

Trial design

106 participants in 1 patient group

Observational Cohort

Description:

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

Treatment:

Device: DES+DCB