Chronic Coronary Insufficiency, Coronary Artery Disease
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEShockwave® Intravascular Lithotripsy System (Shockwave Medical Inc)
IVL is a novel balloon catheter-based device that utilises pulsatile mechanical energy to disrupt calcified lesions. IVL differs from other types of lithotripsy with respect to depth of penetration. It is a single-use, sterile, disposable balloon catheter. The emitters convert electrical energy into transient acoustic circumferential pressure pulses that disrupt both superficial and deep calcium within plaque. The balloon catheter is connected to the generator, which is programmed to deliver the specified dosage of pulses. The IVL balloon, sized 1:1 to the reference artery ratio, is inflated low pressure (4 atm) with 10 pulses of ultrasound energy of 10s delivered per balloon. The procedure is repeated to provide a minimum of 20 pulses in the target lesion, with interval deflation to allow distal perfusion. Each catheter can emit a max of 80 pulses at a rate of one pulse per second. If the lesion exceeds the 12mm balloon length, the balloon can be repositioned and the IVL repeated.
Sponsors
Cardiac Research Institute BV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The MARVEL Pilot STUDY is an investigator-initiated, multicenter, single-arm, open-label, assessing the microcirculation after IVL and PCI in severe calcific stenoses.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Angiographic inclusion criteria * Severely calcified stenoses * Vessels with RVD between 2.5 - 4.0 mm * TIMI flow 3
Exclusion criteria
* Angiographic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Index of Microcirculatory Resistance (IMR) after IVL | through study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Post-PCI FFR after IVL | through study completion, an average of 1 year |
| Rate of periprocedural myocardial infarction | through study completion, an average of 1 year |
Countries
Spain
Outcome results
None listed