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

Coronary Artery Calcification Clinical Trial

— DRAGON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06276114
• Other study ID #: 07
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Coronary Artery Calcification
• Stent Occlusion
• Stent Restenosis

Intervention

Device:
• Stent Underexpansion
Stent underexpansion was diagnosed as stent expansion of <80% assessed with intravascular imaging.

Locations

Country	Name	City	State
Italy	Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital	Florence
Italy	Fabrizio D'Ascenzo	Turin
Poland	Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital	Bialystok
Poland	First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland	Gdansk
Poland	Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland	Katowice
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	Poznan
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	Wroclaw
Poland	Third Department of Cardiology, Medical University of Katowice	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Countries where clinical trial is conducted

Italy,  Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint was device success	Technical success with a final stent expansion =80%.	During procedure
Secondary	Device-oriented composite endpoint (DOCE)	cardiac death, target lesion revascularization, or target vessel myocardial infarction	Thirty days