Clinical trial NCT05112250: IVL for Stent Underexpantsion
Official title: Intravascular Lithotripsy for the Treatment of Stent Underexpansion: the Multicenter IVL-DRAGON Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: In Stent Restenosis
Coronary Artery Calcification
Intravascular Lithotripsy
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Wojciech Wojakowski
First posted: 2021-11-08
Enrollment: 62
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: consecutive patients with stent underexpansion treated with intravascular lithotripsy (IVL)

Brief 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).


Eligibility criteria: Inclusion Criteria:

* stent underexpansion treated with intravascular lithotripsy (IVL)

Exclusion Criteria:

* no

Primary outcomes:
measure: Clinical Success
timeFrame: 30 days
Secondary outcomes:
measure: DOCE
timeFrame: 30 days
Other outcomes:
Locations:
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
city: Katowice
country: Poland
facility: Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
city: Kraków
country: Poland
facility: Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
city: Lubin
country: Poland
facility: Miedziowe Centrum Zdrowia S.A.
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: Poznań
country: Poland
facility: Department of Cardiology
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: