Coronary Artery Disease
Conditions
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
Interventions
DEVICEDES+DCB
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)
Sponsors
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Italy
Outcome results
None listed