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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-10-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Consecutive patients with stent underexpantsion treated with IVL

Stent Underexpansion

Intervention Type DEVICE

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

Consecutive patients with stent underexpantsion treated ELCA

Stent Underexpansion

Intervention Type DEVICE

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

Interventions

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Stent Underexpansion

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

Intervention Type DEVICE

Eligibility Criteria

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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%).

Eligible Sex

ALL

Accepts Healthy Volunteers

No