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

Comparison of Intravascular Coronary Lithotripsy and Excimer Laser Coronary Atherectomy for Severe Stent Underexpansion: the Multicenter IVL- ELCA DRAGON Registry

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Calcification; Stent Restenosis; Intravascular Lithotripsy; Stent Occlusion; Excimer Laser-coronary Atherectomy
• Intervention / Treatment: Device: Stent Underexpansion

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Consecutive patients with stent underexpantsion treated with IVL	Device: Stent Underexpansion; Stent underexpansion was diagnosed as stent expansion of <80% assessed with intravascular imaging.
Consecutive patients with stent underexpantsion treated ELCA	Device: Stent Underexpansion; Stent underexpansion was diagnosed as stent expansion of <80% assessed with intravascular imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary efficacy endpoint was device success	Technical success with a final stent expansion ≥80%.	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-oriented composite endpoint (DOCE)	cardiac death, target lesion revascularization, or target vessel myocardial infarction	Thirty days

Collaborators and Investigators

• Sponsor: Medical University of Silesia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis
• Other Study ID Numbers: 07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No