Coronary Artery Disease
Conditions
Keywords
Drug Coated Balloons, Drug Eluting Stent, Diffuse Disease
Brief 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
Interventions
DEVICEDES+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
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 No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DOCE at 12 Months | 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 |
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 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 |
| DOCE | Pre-discharge, 30 days, 6 months, 12 months | 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 |
| Thrombosis | 12 months | 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). |
| Flow-limiting dissection | 12 months | Flow-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