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

Study Overview
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Brief Summary
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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
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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 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

Official Title
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A Hybrid Approach Evaluating A Drug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease: The HYPER II Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: DES+DCB


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)<br> | Device: DES+DCB<br>* Hybrid approach is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES for a de novo long (>38 mm) lesion (located in the larger, more proximal part of the vessel -reference vessel diameter -RVD >2.75 mm-) and DCB inflation for a concomitant and contiguous de novo small vessel disease (distally located with RVD ≤2.75 mm ≥ 2.0 mm)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TLF in DES/DCB treated segment at 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | 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 3 flow | At procedure | 
| Peri-procedural myocardial infarction | Peri-procedural myocardial infarction defined as an elevation of cardiac biomarkers (troponin or creatine kinase-myocardial band) >3 times the upper limit of normal | Pre-discharge | 
| TLF | TLF and its singular components (cardiac death, any TV-MI excluding peri-procedural MI, ID-TLR) | Pre-discharge, 30 days, 12 months, 24 months | 
| Thrombosis | Any definite/probable DES- or DCB-treated segment thrombosis | In-hospital (within 7 days after PCI), at 30-days, 12 months, 24 months follow-up | 
| Flow-limiting dissection | low-limiting dissection (type C-F waiting 3 minutes after DCB inflation) requiring additional DES implantation in the DCB-treated segment | At procedure |