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

• Conditions: Coronary Artery Disease
• Interventions: Device: DES+DCB

• Registration Number: NCT05650450
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief 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

Detailed 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

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-12-04
• Study First Submitted QC: 2022-12-04
• Study First Posted: 2022-12-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)	DES+DCB	-

Primary Outcome Measures

Name	Time	Method
TLF in DES/DCB treated segment at 12 months	12 months	Target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in the DES- and/or the drug-coated balloon (DCB)-treated segment within 12 months after the index procedure

Secondary Outcome Measures

Name	Time	Method
Peri-procedural myocardial infarction	Pre-discharge	Peri-procedural myocardial infarction defined as an elevation of cardiac biomarkers (troponin or creatine kinase-myocardial band) \>3 times the upper limit of normal
TLF	Pre-discharge, 30 days, 12 months, 24 months	TLF and its singular components (cardiac death, any TV-MI excluding peri-procedural MI, ID-TLR)
Thrombosis	In-hospital (within 7 days after PCI), at 30-days, 12 months, 24 months follow-up	Any definite/probable DES- or DCB-treated segment thrombosis
Flow-limiting dissection	At procedure	low-limiting dissection (type C-F waiting 3 minutes after DCB inflation) requiring additional DES implantation in the DCB-treated segment
Procedural success	At procedure	Procedural success defined as both DCB/DES delivery and implantation at the "target" lesion site with \<30% diameter stenosis (DS) in the DCB-treated segment and \<10% DS in the DES-treated segment and distal TIMI (Thrombolysis in Myocardial Infarction) 3 flow

Trial Locations

Locations (1)

Istituto Clinico S.Ambrogio; 🇮🇹 Milano, Italy