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

Medical University of Silesia

Status: Completed

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

Treatments: Device: Stent Underexpansion

Study type: Observational

Funder types: Other

Identifiers

NCT06276114

07

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

121 participants in 2 patient groups

Consecutive patients with stent underexpantsion treated with IVL

Treatment:

Device: Stent Underexpansion

Consecutive patients with stent underexpantsion treated ELCA

Treatment:

Device: Stent Underexpansion