IVL for Stent Underexpantsion

NCT ID: NCT05112250

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-04-01

Brief Summary

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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

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Conditions

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In Stent Restenosis Coronary Artery Calcification Intravascular Lithotripsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Percutaneous Coronary Intervention

Intravascular lithotripsy (IVL)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* stent underexpansion treated with intravascular lithotripsy (IVL)

Exclusion Criteria

* no
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wojciech Wojakowski

UNKNOWN

Sponsor Role collaborator

Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

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Wojciech Wańha

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital

Bialystok, , Poland

Site Status

First Department of Cardiology, Medical University of Gdansk

Gdansk, , Poland

Site Status

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland

Katowice, , Poland

Site Status

Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland

Krakow, , Poland

Site Status

Miedziowe Centrum Zdrowia S.A.

Lubin, , Poland

Site Status

Department of Cardiology, University Hospital, Institute of Medical Sciences

Opole, , Poland

Site Status

Department of Cardiology, Poznan University of Medical Sciences

Poznan, , Poland

Site Status

Department of Cardiology

Poznan, , Poland

Site Status

Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow

Rzeszów, , Poland

Site Status

1st Department of Cardiology, Medical University of Warsaw

Warsaw, , Poland

Site Status

Department of Cardiology and Internal Diseases, Military Institute of Medicine

Warsaw, , Poland

Site Status

Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland

Warsaw, , Poland

Site Status

Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration

Warsaw, , Poland

Site Status

Department of Invasive Cardiology, Wejherowo

Wejherowo, , Poland

Site Status

Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University

Wroclaw, , Poland

Site Status

Third Department of Cardiology, Medical University of Katowice

Zabrze, , Poland

Site Status

Countries

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Poland

Other Identifiers

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06

Identifier Type: -

Identifier Source: org_study_id