Clinical trial NCT06276114: IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)
Official title: Comparison of Intravascular Coronary Lithotripsy and Excimer Laser Coronary Atherectomy for Severe Stent Underexpansion: the Multicenter IVL- ELCA DRAGON Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Calcification
Intravascular Lithotripsy
Excimer Laser-coronary Atherectomy
Stent Restenosis
Stent Occlusion
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


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%).

Primary outcomes:
measure: The primary efficacy endpoint was device success
timeFrame: During procedure
Secondary outcomes:
measure: Device-oriented composite endpoint (DOCE)
timeFrame: Thirty days
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital
city: Turin
country: Italy
facility: Fabrizio D'Ascenzo
city: Białystok
country: Poland
facility: Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
city: Gdańsk
country: Poland
facility: First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
city: Katowice
country: Poland
facility: Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
city: Kraków
country: Poland
facility: Jacek Legutko
city: Kraków
country: Poland
facility: Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
city: Lubin
country: Poland
facility: 1st Military Hospital in Lublin, Lublin, Poland
city: Lubin
country: Poland
facility: Department of Cardiology, Copper Health Centre (MCZ)
city: Lublin
country: Poland
facility: Clinical Department of Interventional Cardiology, Medical University of Lublin
city: Opole
country: Poland
facility: Department of Cardiology, University Hospital, Institute of Medical Sciences
city: Poznań
country: Poland
facility: Department of Cardiology, Poznan University of Medical Sciences
city: Rzeszów
country: Poland
facility: Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow
city: Warsaw
country: Poland
facility: 1st Department of Cardiology, Medical University of Warsaw
city: Warsaw
country: Poland
facility: Department of Cardiology and Internal Diseases, Military Institute of Medicine
city: Warszawa
country: Poland
facility: Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
city: Warszawa
country: Poland
facility: Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration
city: Wejherowo
country: Poland
facility: Department of Invasive Cardiology, Wejherowo
city: Wrocław
country: Poland
facility: Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University
city: Zabrze
country: Poland
facility: Third Department of Cardiology, Medical University of Katowice
Study officials:
References:
citation: 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.