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

NCT06276114 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2024-02-23

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Stent Underexpansion

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

Sponsors & Collaborators

  • Medical University of Silesia

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • Italy
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06276114 on ClinicalTrials.gov