NCT03939468

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

A HYbrid APproach Evaluating A DRug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	DES+DCB	A hybrid strategy is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES implantation for a de novo lesion (located in the larger, more proximal part of the vessel) and DCB inflation for a concomitant de novo small vessel disease

Timeline

• Start date: 2019-10-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2019-05-06
• Last updated: 2021-01-19

Locations

6 sites across 1 country: Italy