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

Completed

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

• 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

Arm && Interventions

Group	Intervention	Description
Consecutive patients with stent underexpantsion treated ELCA	Stent Underexpansion	-
Consecutive patients with stent underexpantsion treated with IVL	Stent Underexpansion	-

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)

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

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

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

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

Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University; 🇵🇱 Wrocław, Poland

Fabrizio D'Ascenzo; 🇮🇹 Turin, Italy

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

Third Department of Cardiology, Medical University of Katowice; 🇵🇱 Zabrze, Poland

Jacek Legutko; 🇵🇱 Kraków, Poland

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

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

Department of Cardiology, University Hospital, Institute of Medical Sciences; 🇵🇱 Opole, Poland

Department of Cardiology, Poznan University of Medical Sciences; 🇵🇱 Poznań, Poland

1st Department of Cardiology, Medical University of Warsaw; 🇵🇱 Warsaw, Poland

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

Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow; 🇵🇱 Rzeszów, Poland

Department of Cardiology and Internal Diseases, Military Institute of Medicine; 🇵🇱 Warsaw, Poland

Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland; 🇵🇱 Warszawa, Poland

Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration; 🇵🇱 Warszawa, Poland

Department of Invasive Cardiology, Wejherowo; 🇵🇱 Wejherowo, Poland