IVL for Stent Underexpantsion

Completed

• Conditions: In Stent Restenosis; Coronary Artery Calcification; Intravascular Lithotripsy

• Registration Number: NCT05112250
• Lead Sponsor: Medical University of Silesia

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Study First Submitted: 2021-10-19
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-05
• Last Update Submitted: 2021-11-05
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• stent underexpansion treated with intravascular lithotripsy (IVL)

Exclusion Criteria

• no

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Success	30 days	Reduction of stent underexpansion to the value of \<30% with no evidence of in-hospital device-oriented composite end point (DOCE)

Secondary Outcome Measures

Name	Time	Method
DOCE	30 days	composite of cardiac death, target lesion revascularization (TLR), target lesion revascularization, (TLR), and target vessel myocardial infarction (MI)

Trial Locations

Locations (16)

1st Department of Cardiology, Medical University of Warsaw; 🇵🇱 Warsaw, Poland

Department of Cardiology and Internal Diseases, Military Institute of Medicine; 🇵🇱 Warsaw, Poland

First Department of Cardiology, Medical University of Gdansk; 🇵🇱 Gdańsk, Poland

Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital; 🇵🇱 Białystok, Poland

Department of Cardiology; 🇵🇱 Poznań, 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 University of Medical Sciences; 🇵🇱 Poznań, Poland

Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow; 🇵🇱 Rzeszów, Poland

Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland; 🇵🇱 Warszawa, Poland

Department of Invasive Cardiology, Wejherowo; 🇵🇱 Wejherowo, Poland

Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration; 🇵🇱 Warszawa, Poland

Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University; 🇵🇱 Wrocław, Poland

Third Department of Cardiology, Medical University of Katowice; 🇵🇱 Zabrze, Poland