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

Sponsor
Istituto Clinico Sant'Ambrogio (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05650450
Collaborator
(none)
500
1
32.1
15.6

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
  • 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 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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
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

Responsible Party:
ALFONSO IELASI, MD, FESC, Istituto Clinico Sant'Ambrogio
ClinicalTrials.gov Identifier:
NCT05650450
Other Study ID Numbers:
  • HYPER II
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2022