Coronary Artery Calcification, Excimer Laser-coronary Atherectomy, Intravascular Lithotripsy, Stent Occlusion, Stent Restenosis
Conditions
Brief summary
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.
Interventions
DEVICEStent Underexpansion
Stent underexpansion was diagnosed as stent expansion of \<80% assessed with intravascular imaging.
Sponsors
Medical University of Silesia
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Stent underexpansion as stent expansion of \<80% assessed with intravascular imaging (minimum in-stent lumen area divided by average reference lumen area x100%).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary efficacy endpoint was device success | During procedure | Technical success with a final stent expansion ≥80%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-oriented composite endpoint (DOCE) | Thirty days | cardiac death, target lesion revascularization, or target vessel myocardial infarction |
Countries
Italy, Poland
Outcome results
None listed