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

Completed

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

• Registration Number: NCT06276114
• Lead Sponsor: Medical University of Silesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-02
• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-18
• Last Update Submitted: 2024-02-18
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint was device success	During procedure	Technical success with a final stent expansion ≥80%.

Secondary Outcome Measures

Name	Time	Method
Device-oriented composite endpoint (DOCE)	Thirty days	cardiac death, target lesion revascularization, or target vessel myocardial infarction

Trial Locations

Locations (20)

Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital; 🇮🇹 Florence, Italy

Fabrizio D'Ascenzo; 🇮🇹 Turin, Italy

Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital; 🇵🇱 Białystok, Poland

First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland; 🇵🇱 Gdańsk, Poland

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland; 🇵🇱 Katowice, Poland

Jacek Legutko; 🇵🇱 Kraków, Poland

Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland; 🇵🇱 Kraków, Poland

1st Military Hospital in Lublin, Lublin, Poland; 🇵🇱 Lubin, Poland

Department of Cardiology, Copper Health Centre (MCZ); 🇵🇱 Lubin, Poland

Clinical Department of Interventional Cardiology, Medical University of Lublin; 🇵🇱 Lublin, Poland

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