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

Primary Purpose

Coronary Artery Calcification

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Intravascular lithotripsy
Standart therapy
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Calcification focused on measuring Coronary Artery Calcification, Intravascular Lithotripsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiovascular Diseases, University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intrvascular Lithotripsy

Standard therapy

Arm Description

Calcified coronary lesions will be treated with intrvascular lithotripsy

Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy

Outcomes

Primary Outcome Measures

Minimal lumen diamether (MLD)
minimal diamether of treated lesion measured by quantitative coronary angiography
Late luemn loss (LLL)
difference between post-procedure MLD and 12-month MLD

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2020
Last Updated
September 8, 2023
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT04428177
Brief Title
Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions
Acronym
CCS
Official Title
Intravascular Lithotripsy in the Treatment of Calcified Coronary Lesions - Coronary Calcification Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Calcification
Keywords
Coronary Artery Calcification, Intravascular Lithotripsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrvascular Lithotripsy
Arm Type
Experimental
Arm Description
Calcified coronary lesions will be treated with intrvascular lithotripsy
Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy
Intervention Type
Device
Intervention Name(s)
Intravascular lithotripsy
Intervention Description
Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel
Intervention Type
Device
Intervention Name(s)
Standart therapy
Intervention Description
conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy
Primary Outcome Measure Information:
Title
Minimal lumen diamether (MLD)
Description
minimal diamether of treated lesion measured by quantitative coronary angiography
Time Frame
1 year
Title
Late luemn loss (LLL)
Description
difference between post-procedure MLD and 12-month MLD
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Binary in-stent restenosis
Description
diamether stenosis ≥ 50% of reference vessel
Time Frame
1 year
Title
Major adverse cardiac events (MACE)
Description
Cardiac death, myocardial infarction or tagret lesion revascularisation (TVR)
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Angiographic success
Description
success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications
Time Frame
up to end of the procedure, an average of 2 hours
Title
Clinical success
Description
angiographic success with no evidence of in-hospital MACE
Time Frame
up to discharge, an average of 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leos Pleva, MD,PhD.
Phone
+420733414740
Email
leos.pleva@volny.cz
Facility Information:
Facility Name
Department of Cardiovascular Diseases, University Hospital
City
Ostrava
State/Province
Česká Republika
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leos Pleva, MD, PhD
Phone
733414740
Email
leos.pleva@volny.cz
First Name & Middle Initial & Last Name & Degree
Leos Pleva, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pavel Kukla, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions

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