Status:
UNKNOWN
Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions
Lead Sponsor:
University Hospital Ostrava
Conditions:
Coronary Artery Calcification
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04428177
Start Date
June 1 2020
End Date
December 31 2023
Last Update
September 11 2023
Active Locations (1)
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1
Department of Cardiovascular Diseases, University Hospital
Ostrava, Česká Republika, Czechia, 70852