IVL for Stent Underexpantsion

NCT05112250 | Completed DMC

• 1 other identifier: 06
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 16

Brief Summary

The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers. The primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to \<30% with no evidence of in-hospital device-oriented composite end point (DOCE) (defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction).

Conditions

In Stent Restenosis; Coronary Artery Calcification; Intravascular Lithotripsy

Outcome Measures

Primary Outcomes (1)

• Clinical Success

  Reduction of stent underexpansion to the value of \<30% with no evidence of in-hospital device-oriented composite end point (DOCE)

  30 days

Secondary Outcomes (1)

• DOCE

  30 days

Interventions

Percutaneous Coronary Intervention DEVICE

Intravascular lithotripsy (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

consecutive patients with stent underexpansion treated with intravascular lithotripsy (IVL)

You may qualify if:

• stent underexpansion treated with intravascular lithotripsy (IVL)

Sponsors & Collaborators

• Medical University of Silesia: lead
• Wojciech Wojakowski: collaborator

Study Sites (16)

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

Location

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

Katowice, 40-635, Poland

Location

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

Krakow, Poland

Location

Miedziowe Centrum Zdrowia S.A.

Lubin, 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

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

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 8, 2021
• Study Start: November 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

PL (16)