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CompletedNCT06276114DRAGONUpdated Feb 23, 2024

IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)

An observational study in Coronary Artery Calcification, Intravascular Lithotripsy and Excimer Laser-coronary Atherectomy, sponsored by Medical University of Silesia. Completed at 20 sites in 2 countries. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Medical University of Silesia · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
121
Sex
All
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Study summary

The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.

The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint.

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Conditions studied

  • Coronary Artery Calcification
  • Intravascular Lithotripsy
  • Excimer Laser-coronary Atherectomy
  • Stent Restenosis
  • Stent Occlusion

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In context

Calcinosis

182 studies on the registry are indexed under Calcinosis; 33 are open to participants now.

This study's enrollment of 121 is below the median of 172 across 70 observational studies indexed under Calcinosis.

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Lead sponsor

Medical University of Silesia is the lead sponsor of 111 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with underexpanded coronary stent were included regardless of time since stent implantation. Patients who did not undergo intravasuclar imaging during PCI were excluded.

Eligibility criteria

Stent underexpansion as stent expansion of \<80% assessed with intravascular imaging (minimum in-stent lumen area divided by average reference lumen area x100%).

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
121 participants (actual)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • Consecutive patients with stent underexpantsion treated with IVL

    Device: Stent Underexpansion

  • Consecutive patients with stent underexpantsion treated ELCA

    Device: Stent Underexpansion

Interventions

  • DeviceStent Underexpansion

    Stent underexpansion was diagnosed as stent expansion of \<80% assessed with intravascular imaging.

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What researchers measure

Primary outcomes

  1. The primary efficacy endpoint was device success

    Technical success with a final stent expansion ≥80%.

    Time frame: During procedure

Secondary outcomes

  1. Device-oriented composite endpoint (DOCE)

    cardiac death, target lesion revascularization, or target vessel myocardial infarction

    Time frame: Thirty days

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Study locations

20 sites
  • Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital
    Florence, Italy
  • Fabrizio D'Ascenzo
    Turin, Italy
  • Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
    Białystok, Poland
  • First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
    Gdańsk, Poland
  • Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
    Katowice, 40-635, Poland
  • Jacek Legutko
    Kraków, Poland
  • Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
    Kraków, Poland
  • 1st Military Hospital in Lublin, Lublin, Poland
    Lubin, Poland
  • Department of Cardiology, Copper Health Centre (MCZ)
    Lubin, Poland
  • Clinical Department of Interventional Cardiology, Medical University of Lublin
    Lublin, Poland
  • Department of Cardiology, University Hospital, Institute of Medical Sciences
    Opole, Poland
  • Department of Cardiology, Poznan University of Medical Sciences
    Poznań, Poland
  • Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow
    Rzeszów, Poland
  • 1st Department of Cardiology, Medical University of Warsaw
    Warsaw, Poland
  • Department of Cardiology and Internal Diseases, Military Institute of Medicine
    Warsaw, Poland
  • Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
    Warszawa, Poland
  • Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration
    Warszawa, Poland
  • Department of Invasive Cardiology, Wejherowo
    Wejherowo, Poland
  • Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University
    Wrocław, Poland
  • Third Department of Cardiology, Medical University of Katowice
    Zabrze, Poland
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References and documents

Publications

  • Wanha W, Tomaniak M, Wanczura P, Bil J, Januszek R, Wolny R, Opolski MP, Kuzma L, Janas A, Figatowski T, Gasior P, Milewski M, Roleder-Dylewska M, Lewicki L, Kulczycki J, Wlodarczak A, Tomasiewicz B, Iwanczyk S, Sacha J, Koltowski L, Dziarmaga M, Jaguszewski M, Kralisz P, Olajossy B, Sobieszek G, Dyrbus K, Lebek M, Smolka G, Reczuch K, Gil RJ, Dobrzycki S, Kwiatkowski P, Rogala M, Gasior M, Ochala A, Kochman J, Witkowski A, Lesiak M, D'Ascenzo F, Bartus S, Wojakowski W. Intravascular Lithotripsy for the Treatment of Stent Underexpansion: The Multicenter IVL-DRAGON Registry. J Clin Med. 2022 Mar 23;11(7):1779. doi: 10.3390/jcm11071779. PubMed 35407387 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06276114
Lead sponsor
Medical University of Silesia
Responsible party
Wojciech Wańha (MD, PhD, Prof. Ass., Medical University of Silesia) — Principal investigator
First posted
Feb 23, 2024
Start date
Aug 1, 2020
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023
Last update
Feb 23, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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