Coronary Artery CalcificationCCSNCT04428177
Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions
A study testing Intravascular lithotripsy and Standart therapy in people with Coronary Artery Calcification, run by University Hospital Ostrava at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Calcification
- What is being tested?
- Intravascular lithotripsy and Standart therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Diseases, University Hospital
Ostrava, Česká Republika, 70852
Leos Pleva, MD, PhD, 733414740, leos.pleva@volny.cz
Leos Pleva, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Calcification
- Being tested
- Intravascular lithotripsy, Standart therapy
- Keywords
- Coronary Artery Calcification, Intravascular Lithotripsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular lithotripsyDevice
Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel
Standart therapyDevice
conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy
| Study group | Role | What they receive |
|---|---|---|
| Intrvascular Lithotripsy | Experimental | Calcified coronary lesions will be treated with intrvascular lithotripsy Receives: Device: Intravascular lithotripsy |
| Standard therapy | Active comparator | Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy Receives: Device: Standart therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal lumen diamether (MLD)
minimal diamether of treated lesion measured by quantitative coronary angiography
Measured: 1 year
Late luemn loss (LLL)
difference between post-procedure MLD and 12-month MLD
Measured: 1 year
Secondary outcomes (2)
Binary in-stent restenosis
diamether stenosis ≥ 50% of reference vessel
Measured: 1 year
Major adverse cardiac events (MACE)
Cardiac death, myocardial infarction or tagret lesion revascularisation (TVR)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428177
- Sponsor's protocol ID
- 06/RVO-FNOs/2020
- Acronym
- CCS
- Status last verified
- Sep 2023
- First submitted
- 2 Jun 2020
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pleva L, Kukla P, Konde A. Comparison of the efficacy of intravascular lithotripsy and rotational atherectomy as adjunctive therapy before drug-eluting stent implantation in calcified coronary lesions (CCS- Coronary Calcification Study). BMC Cardiovasc Disord. 2025 Sep 2;25(1):648. doi: 10.1186/s12872-025-05082-z.
PubMed 40898049
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Lithotripsy in the Treatment of Calcified Coronary Lesions - Coronary Calcification Study
- ClinicalTrials.gov ID
- NCT04428177
- Acronym / sponsor ID
- CCS / 06/RVO-FNOs/2020
- Conditions
- Coronary Artery Calcification
- Keywords
- Coronary Artery Calcification, Intravascular Lithotripsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrvascular Lithotripsy | Experimental | Device: Intravascular lithotripsyCalcified coronary lesions will be treated with intrvascular lithotripsy |
| Standard therapy | Active comparator | Device: Standart therapyStandard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Native coronary artery lesion with diameter stenosis ≥50% suitable for PCI
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular lithotripsyIntravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel | Device | Intrvascular Lithotripsy |
| Standart therapyconventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy | Device | Standard therapy |
Primary outcome
Minimal lumen diamether (MLD)
Time frame: 1 year
minimal diamether of treated lesion measured by quantitative coronary angiography
Late luemn loss (LLL)
Time frame: 1 year
difference between post-procedure MLD and 12-month MLD
2 secondary outcomes
Binary in-stent restenosis
Time frame: 1 year
Major adverse cardiac events (MACE)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 40898049Pleva L, Kukla P, Konde A. Comparison of the efficacy of intravascular lithotripsy and rotational atherectomy as adjunctive therapy before drug-eluting stent implantation in calcified coronary lesions (CCS- Coronary Calcification Study). BMC Cardiovasc Disord. 2025 Sep 2;25(1):648. doi: 10.1186/s12872-025-05082-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular lithotripsy and Standart therapy in people with Coronary Artery Calcification, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leos Pleva, MD,PhD. (+420733414740, leos.pleva@volny.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal lumen diamether (MLD) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04428177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.