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Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent for de Novo Diffuse Disease Treatment

  • identifier


  • Recruitment Status

    Active, not recruiting

  • First Posted

    May 6, 2019

  • Last update posted

    January 19, 2021

Study Description

Brief summary:

A Pilot Observational Study to evaluate safety and efficacy of the hybrid approach DES/DCB in treating de-novo diffuse lesions

  • Condition or Disease:Coronary Artery Disease
  • Intervention/Treatment: Device: DES+DCB
  • Phase: N/A

Detailed Description

This is a prospective, non-randomized, single-arm, multi-center, pilot, noninterventional study whose aim is 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. 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]
  • Actual Enrollment: 106 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 De Novo Diffuse Coronary Artery Disease
  • Actual Study Start Date: October 2019
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: January 2022

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: Observational Cohort
Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)
Device: DES+DCB
A hybrid strategy is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES implantation for a de novo lesion (located in the larger, more proximal part of the vessel) and DCB inflation for a concomitant de novo small vessel disease

Outcome Measures

  • Primary Outcome Measures: 1. DOCE at 12 Months [ Time Frame: 12 Months ]
    A device oriented composite end-point (DOCE) of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in the DES- and/or the DCB-treated segment within 12 months after the index procedure
  • Secondary Outcome Measures: 1. Procedural Success [ Time Frame: 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 [ Time Frame: 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. DOCE [ Time Frame: Pre-discharge, 30 days, 6 months, 12 months ]
    DOCE and its singular components (cardiac death, any TV-MI excluding peri-procedural MI, ID-TLR ) in-hospital, (within 7 days after PCI) and at 30-day, 6-month, 1-year follow-up
  • 4. Thrombosis [ Time Frame: 12 months ]
    Any definite/probable DES- or DCB-treated segment thrombosis (in-hospital, within 7 days after PCI and at 30-day, 6month, 1-year follow-up).
  • 5. Flow-limiting dissection [ Time Frame: 12 months ]
    Flow-limiting dissection (type C-F waiting 3 minutes after DCB inflation) requiring additional DES implantation in the DCB-treated segment

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: Patients with stable or unstable CAD eligible for PCI (according to International guidelines) due to diffuse disease (located in the same vessel) suitable for a "hybrid approach" (see below) will be enrolled after signing the informed consent. A hybrid strategy was defined as overlapping or slightly (2-3 mm) superimposing a new generation DES implantation for a de novo lesion (located in the larger, more proximal part of the vessel) and DCB inflation for a concomitant de novo small vessel disease (located in the smaller distal segment or at a side branch of a bifurcation in the same coronary artery). Diffuse disease is defined as CAD≥28 mm in length involving distal segments or side branches of a bifurcation lesion with a reference vessel diameter (RVD) considered suitable for a hybrid approach in case of ≥2.75 mm RVD for a DEStarget segment and ≥2.0 mm to <2.75 mm RVD for a DCB-target segment.


Inclusion Criteria:

- Patients presenting with stable or unstable CAD eligible for PCI (according to the
international guidelines) because of diffuse CAD involving segments suitable for a
hybrid approach;

- Signed Patient Informed Consent/Data Release Form

Exclusion Criteria:

1. Age <18 years; 2. Cardiogenic shock; 3. Pregnancy or breastfeeding; 4. Infarct-artery max diameter (within planned device deployment segment) 5.0

5. Comorbidities with life expectancy <6 months; 6. Severe calcification or/tortuosity proximally or at the DCB target segment;

Contacts and Locations



Italy, Milano
Presidio Ospedaliero di Rho

Italy, Milano
Istituto Clinico Humanitas

Istituto Clinico S.Anna

ASST Ospedale Cremona

Istituto Clinico S.Ambrogio

Policlinico Casilino

Sponsors and Collaborators

Istituto Clinico Sant'Ambrogio

More Information