Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions (CCS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Calcification
• Intervention / Treatment: Device: Intravascular lithotripsy; Device: Standart therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leos Pleva, MD,PhD.; Phone Number: +420733414740; Email: leos.pleva@volny.cz

Study Locations

• Czechia
  • Česká Republika
    • Ostrava, Česká Republika, Czechia, 70852
      • Recruiting
      • Department of Cardiovascular Diseases, University Hospital
      • Contact: Leos Pleva, MD, PhD; Phone Number: 733414740; Email: leos.pleva@volny.cz
      • Principal Investigator: Leos Pleva, MD, PhD
      • Sub-Investigator: Pavel Kukla, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrvascular Lithotripsy; Calcified coronary lesions will be treated with intrvascular lithotripsy	Device: Intravascular lithotripsy; Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel
Active Comparator: Standard therapy; Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy	Device: Standart therapy; conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal lumen diamether (MLD)	minimal diamether of treated lesion measured by quantitative coronary angiography	1 year
Late luemn loss (LLL)	difference between post-procedure MLD and 12-month MLD	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binary in-stent restenosis	diamether stenosis ≥ 50% of reference vessel	1 year
Major adverse cardiac events (MACE)	Cardiac death, myocardial infarction or tagret lesion revascularisation (TVR)	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Clinical success	angiographic success with no evidence of in-hospital MACE	up to discharge, an average of 3 days

Collaborators and Investigators

• Sponsor: University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Calcification; Intravascular Lithotripsy
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis
• Other Study ID Numbers: 06/RVO-FNOs/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No