Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions
NCT ID: NCT04428177
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-06-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intrvascular Lithotripsy
Calcified coronary lesions will be treated with intrvascular lithotripsy
Intravascular lithotripsy
Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel
Standard therapy
Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy
Standart therapy
conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Locations
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Department of Cardiovascular Diseases, University Hospital
Ostrava, Česká Republika, Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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06/RVO-FNOs/2020
Identifier Type: -
Identifier Source: org_study_id
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