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OpenTrials
Completed

NCT Number: NCT06276114

IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)

The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.

The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint.

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Key information

Conditions

Coronary Artery Calcification Excimer Laser-coronary Atherectomy Intravascular Lithotripsy Stent Occlusion Stent Restenosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital, Florence, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Stent underexpansion as stent expansion of <80% assessed with intravascular imaging (minimum in-stent lumen area divided by average reference lumen area x100%).

Treatment and study plan

Stent Underexpansion

Device

Stent underexpansion was diagnosed as stent expansion of <80% assessed with intravascular imaging.

Primary outcomes

  1. The primary efficacy endpoint was device success

    Time frame: During procedure

    Technical success with a final stent expansion ≥80%.

Secondary outcomes

  1. Device-oriented composite endpoint (DOCE)

    Time frame: Thirty days

    cardiac death, target lesion revascularization, or target vessel myocardial infarction

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

Comparison of Intravascular Coronary Lithotripsy and Excimer Laser Coronary Atherectomy for Severe Stent Underexpansion: the Multicenter IVL- ELCA DRAGON Registry

Acronym: DRAGON

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

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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