Microcirculatory Status After Intravascular Lithotripsy

Status Completed

Clinical Trial Summary

Due to differences in the mechanism of action, intravascular lithotripsy is likely to cause less distal embolization and microcirculatory dysfunction during plaque preparation. This may also translate into lower periprocedural myocardial infarction rates. Thus, this exploratory study aims to evaluate the microcirculatory function after the use of Shockwave® intravascular lithotripsy.

Clinical Trial Description

Patients with stable coronary artery disease or stabilized acute coronary syndromes with severely calcified de novo coronary stenoses with indication of plaque modification technique during PCI. Due to differences in the mechanism of action, intravascular lithotripsy is likely to cause less distal embolization and microcirculatory dysfunction during plaque preparation. This may also translate into lower periprocedural myocardial infarction rates. To perform the invasive physiology assessment an intracoronary pressure and temperature sensor-tipped guidewire is used to measure distal coronary pressure and to derive thermodilution curves. For the calculation of IMR three thermodilution curves can be obtained from a hand-held, 3-ml rapid (<0.25s) injection of room temperature saline at baseline and during maximal hyperemia. Mean transit time (Tmn) at baseline and during maximal hyperemia is derived from the thermodilution curves. Simultaneous recordings of mean aortic pressure (guiding catheter, Pa) and mean distal coronary pressure (distal pressure sensor, Pd) is also obtained at baseline and during maximal hyperemia. The IMR is then calculated using the following equation: IMR = PaxTmn[(Pd-Pw)/(Pa-Pw)], where Pw is the coronary wedge pressure. Pw will be measured as the distal coronary pressure (from the distal pressure and temperature sensor) during complete balloon occlusion of the vessel obtained during PCI. The aim of the present study is to investigate the protective effect of IVL (Shockwave© Medical) on the coronary microcirculatory during PCI in calcific coronary stenosis, compared to RA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05134051
Study type	Interventional
Source	Cardiac Research Institute BV
Contact
Status	Completed
Phase	N/A
Start date	October 6, 2020
Completion date	December 31, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Microcirculatory Status After Intravascular Lithotripsy — MARVEL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms