Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions

Coronary Artery Calcification Clinical Trial

— CCS  

Official title:

Intravascular Lithotripsy in the Treatment of Calcified Coronary Lesions - Coronary Calcification Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04428177
• Other study ID #: 06/RVO-FNOs/2020
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: University Hospital Ostrava
• Contact: Leos Pleva, MD,PhD.
• Phone: +420733414740
• Email: leos.pleva[@]volny.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective randomised study is to compare the safety and efficacy of novel intravascular lithotripsy (IVL) to the standard therapy of calcified coronary lesions.

Description:

The study will include a total of 40 patients with calcified coronary lesions who will be randomised 1:1 to the treatment with IVL (Shockwave; Shockwave Medical, Inc, Santa Clara, USA) or the standard therapy (non-compliat high-pressure or Scoreflex predilatation, rotational atherectomy, etc). Appropriate preparation of the lesions will be followed by DES implantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years
• Informed, written consent by the patient
• Ability to comply fully with the study protocol
• Negative pregnancy test (and effective contraception) in women with childbearing potential

Angiographic inclusion criteria:

• Native coronary artery lesion with diameter stenosis =50% suitable for PCI
• Heavy calcification, defined as calcification within the lesion on both sides of the vessel assessed during angiography
• Reference vessel diameter (RVD) =2.5 mm with lesion length <32 mm
• TIMI flow 3 of the target vessel at baseline
• No visible thrombus at target lesion site

Exclusion Criteria:

• Cardiogenic shock or haemodynamic instability requiring mechanical circulatory support
• Active malignancy or other comorbidities with a life expectancy of 12 months
• Limited the possibility of control coronaro angiography (e.g., advanced renal failure)
• Known allergy to contrast agents (that cannot be adequately premedicated) or required concomitant dual antiplatelet therapy
• Current problems with substance abuse (e.g., alcohol or drugs)
• Subject is participating in another investigational drug or device clinical study

Related Conditions & MeSH terms

• Calcinosis
• Coronary Artery Calcification

Intervention

Device:
• Intravascular lithotripsy
Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel
• Standart therapy
conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy

Locations

Country	Name	City	State
Czechia	Department of Cardiovascular Diseases, University Hospital	Ostrava	Ceská Republika

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Angiographic success	success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications	up to end of the procedure, an average of 2 hours
Other	Clinical success	angiographic success with no evidence of in-hospital MACE	up to discharge, an average of 3 days
Primary	Minimal lumen diamether (MLD)	minimal diamether of treated lesion measured by quantitative coronary angiography	1 year
Primary	Late luemn loss (LLL)	difference between post-procedure MLD and 12-month MLD	1 year
Secondary	Binary in-stent restenosis	diamether stenosis = 50% of reference vessel	1 year
Secondary	Major adverse cardiac events (MACE)	Cardiac death, myocardial infarction or tagret lesion revascularisation (TVR)	1 year