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

NCT06276114 | Completed

• 1 other identifier: 07
• Study Type: observational
• Target: 121
• Locations: 2 countries
• Sites: 20

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint was device success

  Technical success with a final stent expansion ≥80%.

  During procedure

Secondary Outcomes (1)

• Device-oriented composite endpoint (DOCE)

  Thirty days

Study Arms (2)

Consecutive patients with stent underexpantsion treated with IVL

Device: Stent Underexpansion

Consecutive patients with stent underexpantsion treated ELCA

Device: Stent Underexpansion

Interventions

Stent Underexpansion DEVICE

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

Consecutive patients with stent underexpantsion treated ELCA; Consecutive patients with stent underexpantsion treated with IVL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with underexpanded coronary stent were included regardless of time since stent implantation. Patients who did not undergo intravasuclar imaging during PCI were excluded.

Stent underexpansion as stent expansion of \<80% assessed with intravascular imaging (minimum in-stent lumen area divided by average reference lumen area x100%).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (20)

Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital

Florence, Italy

Location

Fabrizio D'Ascenzo

Turin, Italy

Location

Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital

Bialystok, Poland

Location

First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland

Gdansk, Poland

Location

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

Katowice, 40-635, Poland

Location

Jacek Legutko

Krakow, Poland

Location

Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland

Krakow, Poland

Location

1st Military Hospital in Lublin, Lublin, Poland

Lubin, Poland

Location

Department of Cardiology, Copper Health Centre (MCZ)

Lubin, Poland

Location

Clinical Department of Interventional Cardiology, Medical University of Lublin

Lublin, Poland

Location

Department of Cardiology, University Hospital, Institute of Medical Sciences

Opole, Poland

Location

Department of Cardiology, Poznan University of Medical Sciences

Poznan, Poland

Location

Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow

Rzeszów, Poland

Location

1st Department of Cardiology, Medical University of Warsaw

Warsaw, Poland

Location

Department of Cardiology and Internal Diseases, Military Institute of Medicine

Warsaw, Poland

Location

Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland

Warsaw, Poland

Location

Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration

Warsaw, Poland

Location

Department of Invasive Cardiology, Wejherowo

Wejherowo, Poland

Location

Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University

Wroclaw, Poland

Location

Third Department of Cardiology, Medical University of Katowice

Zabrze, Poland

Location

Related Publications (1)

• Wanha W, Tomaniak M, Wanczura P, Bil J, Januszek R, Wolny R, Opolski MP, Kuzma L, Janas A, Figatowski T, Gasior P, Milewski M, Roleder-Dylewska M, Lewicki L, Kulczycki J, Wlodarczak A, Tomasiewicz B, Iwanczyk S, Sacha J, Koltowski L, Dziarmaga M, Jaguszewski M, Kralisz P, Olajossy B, Sobieszek G, Dyrbus K, Lebek M, Smolka G, Reczuch K, Gil RJ, Dobrzycki S, Kwiatkowski P, Rogala M, Gasior M, Ochala A, Kochman J, Witkowski A, Lesiak M, D'Ascenzo F, Bartus S, Wojakowski W. Intravascular Lithotripsy for the Treatment of Stent Underexpansion: The Multicenter IVL-DRAGON Registry. J Clin Med. 2022 Mar 23;11(7):1779. doi: 10.3390/jcm11071779.

  PMID: 35407387 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Prof. Ass.

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 23, 2024
• Study Start: August 1, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

IT (2); PL (18)