Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease (HYPER II)

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: DES+DCB

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

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy
    • Istituto Clinico S.Ambrogio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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). Hybrid approach is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: December 4, 2022
• First Submitted That Met QC Criteria: December 4, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: HYPER II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No