Clinical trial NCT05134051: Microcirculatory Status After Intravascular Lithotripsy
Official title: Microcirculatory Status After Intravascular Lithotripsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Coronary Insufficiency
Coronary Artery Disease
Lead sponsor: Cardiac Research Institute BV
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Angiographic inclusion criteria

  * Severely calcified stenoses
  * Vessels with RVD between 2.5 - 4.0 mm
  * TIMI flow 3

Exclusion Criteria:

* Angiographic exclusion criteria

  * Concomitant use of rotational atherectomy
  * Severe vessel tortuosity
  * Stenosis un-crossable with a balloon/guidewire
  * Concomitant conditions
  * Contraindication for adenosine administration.
  * Hemodynamic or electrical instability.
  * Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN.
  * Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2, unless the patient is in renal support therapy.
* Other exclusion criteria

  * Unable to provide written informed consent (IC)
  * Known pregnancy or breast-feeding at time of inclusion; pre-menopausal women, unless sterilized, must take an effective method of birth control up to 15 weeks after the end of treatment with IP
  * Prior myocardial infarction subtended to the PCI target vessel.
  * Akinesia or dyskinesia in myocardial segments in the distribution area of the PCI target vessel.
  * Severe systolic dysfunction defined as left ventricular ejection fraction \< 35%.
  * Patent arterial or venous surgical graft supplying the PCI target vessel.
  * Previous TIMI flow \< 1 before guidewire crossing.
  * Patient not eligible for drug-eluting stent treatment.

Primary outcomes:
measure: Index of Microcirculatory Resistance (IMR) after IVL
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Post-PCI FFR after IVL
timeFrame: through study completion, an average of 1 year
measure: Rate of periprocedural myocardial infarction
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital San Carlos
Study officials:
affiliation: Cardiovascular Center OLV Aalst
name: Carlos Collet
role: PRINCIPAL_INVESTIGATOR
References: