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IVL for Stent Underexpantsion

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05112250
Acronym
IVL-DRAGON
Enrollment
62
Registered
2021-11-08
Start date
2019-11-01
Completion date
2021-04-01
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Calcification, In Stent Restenosis, Intravascular Lithotripsy

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).

Interventions

DEVICEPercutaneous Coronary Intervention

Intravascular lithotripsy (IVL)

Sponsors

Wojciech Wojakowski
CollaboratorUNKNOWN
Medical University of Silesia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* stent underexpansion treated with intravascular lithotripsy (IVL)

Exclusion criteria

* no

Design outcomes

Primary

MeasureTime frameDescription
Clinical Success30 daysReduction of stent underexpansion to the value of \<30% with no evidence of in-hospital device-oriented composite end point (DOCE)

Secondary

MeasureTime frameDescription
DOCE30 dayscomposite of cardiac death, target lesion revascularization (TLR), target lesion revascularization, (TLR), and target vessel myocardial infarction (MI)

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026