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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05650450
Other study ID # HYPER II
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date January 1, 2025

Study information

Verified date January 2024
Source I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 500
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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.

Study Design


Intervention

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)

Locations

Country Name City State
Italy Istituto Clinico S.Ambrogio Milano

Sponsors (1)

Lead Sponsor Collaborator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary TLF in DES/DCB treated segment at 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 12 months
Secondary 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 (Thrombolysis in Myocardial Infarction) 3 flow At procedure
Secondary 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 Pre-discharge
Secondary TLF TLF and its singular components (cardiac death, any TV-MI excluding peri-procedural MI, ID-TLR) Pre-discharge, 30 days, 12 months, 24 months
Secondary Thrombosis Any definite/probable DES- or DCB-treated segment thrombosis In-hospital (within 7 days after PCI), at 30-days, 12 months, 24 months follow-up
Secondary Flow-limiting dissection low-limiting dissection (type C-F waiting 3 minutes after DCB inflation) requiring additional DES implantation in the DCB-treated segment At procedure
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