IVL for Stent Underexpantsion

Coronary Artery Calcification Clinical Trial

— IVL-DRAGON  

Official title:

Intravascular Lithotripsy for the Treatment of Stent Underexpansion: the Multicenter IVL-DRAGON Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05112250
• Other study ID #: 06
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: November 2021
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers. The primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to <30% with no evidence of in-hospital device-oriented composite end point (DOCE) (defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• stent underexpansion treated with intravascular lithotripsy (IVL)

Exclusion Criteria:

• no

Related Conditions & MeSH terms

• Calcinosis
• Coronary Artery Calcification
• In Stent Restenosis

Intervention

Device:
• Percutaneous Coronary Intervention
Intravascular lithotripsy (IVL)

Locations

Country	Name	City	State
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	Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland	Katowice
Poland	Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland	Kraków
Poland	Miedziowe Centrum Zdrowia S.A.	Lubin
Poland	Department of Cardiology, University Hospital, Institute of Medical Sciences	Opole
Poland	Department of Cardiology	Poznan
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 (2)

Lead Sponsor	Collaborator
Medical University of Silesia	Wojciech Wojakowski

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success	Reduction of stent underexpansion to the value of <30% with no evidence of in-hospital device-oriented composite end point (DOCE)	30 days
Secondary	DOCE	composite of cardiac death, target lesion revascularization (TLR), target lesion revascularization, (TLR), and target vessel myocardial infarction (MI)	30 days