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Trial record 1 of 1 for:    NCT03939468
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Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent for de Novo Diffuse Disease Treatment (HYPER)

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ClinicalTrials.gov Identifier: NCT03939468
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
ALFONSO IELASI, Istituto Clinico Sant'Ambrogio

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 Intervention/treatment
Coronary Artery Disease Device: DES+DCB

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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




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



Information from the National Library of Medicine

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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.
Criteria

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) <2.0 or >5.0 mm;
  5. Comorbidities with life expectancy <6 months;
  6. Severe calcification or/tortuosity proximally or at the DCB target segment;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939468


Locations
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Italy
Presidio Ospedaliero di Rho Not yet recruiting
Rho, Milano, Italy
Contact: Giuseppe De Angelis, MD         
Principal Investigator: Giuseppe De Angelis, MD         
Sub-Investigator: Susanna Benincasa, MD         
Istituto Clinico S.Anna Not yet recruiting
Brescia, Italy
Contact: Delio Tedeschi, MD         
Principal Investigator: Delio Tedeschi, MD         
ASST Ospedale Cremona Not yet recruiting
Cremona, Italy
Contact: Marco Loffi, MD         
Principal Investigator: Marco Loffi, MD         
Istituto Clinico S.Ambrogio Not yet recruiting
Milano, Italy
Contact: Alfonso Ielasi, MD       alielasi@hotmail.com   
Principal Investigator: Alfonso Ielasi, MD         
Sponsors and Collaborators
Istituto Clinico Sant'Ambrogio

Publications:
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Responsible Party: ALFONSO IELASI, Principal Investigator, Istituto Clinico Sant'Ambrogio
ClinicalTrials.gov Identifier: NCT03939468     History of Changes
Other Study ID Numbers: HYPER v2
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ALFONSO IELASI, Istituto Clinico Sant'Ambrogio:
Drug Coated Balloons
Drug Eluting Stent
Diffuse Disease

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases