HYPER II: Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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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 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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)
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Device: DES+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)
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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);
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Signed Patient Informed Consent/Data Release Form
Exclusion Criteria:
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Age <18 years;
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Cardiogenic shock;
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Pregnancy or breastfeeding;
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Target vessel reference diameter (within planned device deployment segments) <2.0 or
5.0 mm;
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Comorbidities with life expectancy <12 months
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Severe calcification or/tortuosity proximally or at the DCB target segment;
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Prior PCI and stent implantation in the target vessel.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Istituto Clinico S.Ambrogio | Milano | Italy |
Sponsors and Collaborators
- Istituto Clinico Sant'Ambrogio
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Ielasi A, Buono A, Pellicano M, Tedeschi D, Loffi M, Donahue M, Regazzoli D, De Angelis G, Danzi G, Reimers B, Tespili M. A HYbrid APproach Evaluating a DRug-Coated Balloon in Combination With a New-Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease: The HYPER Pilot Study. Cardiovasc Revasc Med. 2021 Jul;28:14-19. doi: 10.1016/j.carrev.2020.07.036. Epub 2020 Jul 31.
- Ielasi A, Miyazaki T, Geraci S, Testa L, Abdel-Wahab M, Kawamoto H, Ruparelia N, Sato T, Caramanno G, Bedogni F, Tespili M, Colombo A, Latib A. Hybrid strategy with a bioresorbable scaffold and a drug-coated balloon for diffuse coronary artery disease: the "no more metallic cages" multicentre pilot experience. EuroIntervention. 2016 Apr 8;11(14):e1589-95. doi: 10.4244/EIJV11I14A309.
- HYPER II