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Coronary Artery DiseaseHYPERNCT03939468

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

An observational study of Coronary Artery Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 6 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
DES+DCB
Type of treatment
Medical device
How many people
106 participants
Where
6 sitesItaly
Study dates
1 Oct 2019to 1 Jan 2022
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Age <18 years;
  • Cardiogenic shock;
  • Pregnancy or breastfeeding;
  • Infarct-artery max diameter (within planned device deployment segment) <2.0 or >5.0 mm;
  • Comorbidities with life expectancy <6 months;
  • Severe calcification or/tortuosity proximally or at the DCB target segment;

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Italy6 sites

  • Istituto Clinico S.Anna

    Brescia

  • ASST Ospedale Cremona

    Cremona

  • Istituto Clinico S.Ambrogio

    Milan

  • Presidio Ospedaliero di Rho

    Rho, Milano

  • Policlinico Casilino

    Roma

  • Istituto Clinico Humanitas

    Rozzano, Milano

Other trials in Italy

About this study

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

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

Read the 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

Being tested
DES+DCB
Keywords
Drug Coated Balloons, Drug Eluting Stent, Diffuse Disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DES+DCBDevice

    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

Study groups in NCT03939468
Study groupRoleWhat they receive
Observational CohortPatient with diffuse CAD disease treated with hybrid strategy (DES+DCB)
Receives: Device: DES+DCB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DOCE at 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

    Measured: 12 Months

Secondary outcomes (5)

  1. 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 3 flow.

    Measured: At procedure

  2. 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

    Measured: Pre-discharge

  3. DOCE

    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

    Measured: Pre-discharge, 30 days, 6 months, 12 months

  4. Thrombosis

    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).

    Measured: 12 months

  5. Flow-limiting dissection

    Flow-limiting dissection (type C-F waiting 3 minutes after DCB inflation) requiring additional DES implantation in the DCB-treated segment

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start1 Oct 2019
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
106 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03939468
Sponsor's protocol ID
HYPER v3
Acronym
HYPER
Status last verified
Jan 2021
First submitted
2 May 2019
Last updated
19 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Costopoulos C, Latib A, Naganuma T, Sticchi A, Figini F, Basavarajaiah S, Carlino M, Chieffo A, Montorfano M, Naim C, Kawaguchi M, Giannini F, Colombo A. The role of drug-eluting balloons alone or in combination with drug-eluting stents in the treatment of de novo diffuse coronary disease. JACC Cardiovasc Interv. 2013 Nov;6(11):1153-9. doi: 10.1016/j.jcin.2013.07.005.

    PubMed 24262615

  • 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.

    PubMed 27056119

  • Tang Y, Qiao S, Su X, Chen Y, Jin Z, Chen H, Xu B, Kong X, Pang W, Liu Y, Yu Z, Li X, Li H, Zhao Y, Wang Y, Li W, Tian J, Guan C, Xu B, Gao R; RESTORE SVD China Investigators. Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2381-2392. doi: 10.1016/j.jcin.2018.09.009.

    PubMed 30522667

  • 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.

    PubMed 32933874

  • Buono A, Pellicano M, Regazzoli D, Donahue M, Tedeschi D, Loffi M, Zimbardo G, Reimers B, Danzi G, DE Blasio G, Tespili M, Ielasi A. Procedural and one-year outcomes following drug-eluting stent and drug-coated balloon combination for the treatment of de novo diffuse coronary artery disease: the HYPER Study. Minerva Cardiol Angiol. 2024 Apr;72(2):163-171. doi: 10.23736/S2724-5683.23.06352-4. Epub 2023 Sep 13.

    PubMed 37705369

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 6 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DOCE at 12 Months (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03939468, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.

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