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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio106 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

106

Conditions

Coronary Artery Disease

Interventions

DES+DCBDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (6)

Presidio Ospedaliero di Rho

Rho, Milano, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Istituto Clinico S.Anna

Brescia, Italy

ASST Ospedale Cremona

Cremona, Italy

Outcomes

Primary Outcomes

DOCE at 12 Months

A device oriented composite end-point (DOCE) of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in the DES- and/or the DCB-treated segment within 12 months after the index procedure

Time frame: 12 Months

Secondary Outcomes

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.

Time frame: 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

Time frame: Pre-discharge

DOCE

DOCE and its singular components (cardiac death, any TV-MI excluding peri-procedural MI, ID-TLR ) in-hospital, (within 7 days after PCI) and at 30-day, 6-month, 1-year follow-up

Time frame: Pre-discharge, 30 days, 6 months, 12 months

Thrombosis

Any definite/probable DES- or DCB-treated segment thrombosis (in-hospital, within 7 days after PCI and at 30-day, 6month, 1-year follow-up).

Time frame: 12 months

Flow-limiting dissection

Flow-limiting dissection (type C-F waiting 3 minutes after DCB inflation) requiring additional DES implantation in the DCB-treated segment

Time frame: 12 months

Data from ClinicalTrials.gov

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