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OpenTrials
Completed

NCT Number: NCT05112250

IVL for Stent Underexpantsion

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).

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Key information

Conditions

In Stent Restenosis Coronary Artery Calcification Intravascular Lithotripsy

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • stent underexpansion treated with intravascular lithotripsy (IVL)

Exclusion criteria

  • no

Treatment and study plan

Percutaneous coronary intervention

Device

Intravascular lithotripsy (IVL)

Primary outcomes

  1. Clinical Success

    Time frame: 30 days

    Reduction of stent underexpansion to the value of <30% with no evidence of in-hospital device-oriented composite end point (DOCE)

Secondary outcomes

  1. DOCE

    Time frame: 30 days

    composite of cardiac death, target lesion revascularization (TLR), target lesion revascularization, (TLR), and target vessel myocardial infarction (MI)

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • Wojciech Wojakowski

Registry information

Official study title

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

Acronym: IVL-DRAGON

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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