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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- TLF in DES/DCB treated segment at 12 months
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
TLF in DES/DCB treated segment at 12 months
Time Frame: 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 Outcomes
- Peri-procedural myocardial infarction(Pre-discharge)
- TLF(Pre-discharge, 30 days, 12 months, 24 months)
- Thrombosis(In-hospital (within 7 days after PCI), at 30-days, 12 months, 24 months follow-up)
- Flow-limiting dissection(At procedure)
- Procedural success(At procedure)