Trials / Completed
CompletedNCT06276114
IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)
Comparison of Intravascular Coronary Lithotripsy and Excimer Laser Coronary Atherectomy for Severe Stent Underexpansion: the Multicenter IVL- ELCA DRAGON Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 121 (actual)
- Sponsor
- Medical University of Silesia · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Stent Underexpansion | Stent underexpansion was diagnosed as stent expansion of \<80% assessed with intravascular imaging. |
Timeline
- Start date
- 2020-08-01
- Primary completion
- 2023-10-31
- Completion
- 2023-10-31
- First posted
- 2024-02-23
- Last updated
- 2024-02-23
Locations
20 sites across 2 countries: Italy, Poland
Source: ClinicalTrials.gov record NCT06276114. Inclusion in this directory is not an endorsement.