Microcirculatory Status After Intravascular Lithotripsy

NCT05134051 | Completed DMC

• 1 other identifier: 2020/066
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Coronary Insufficiency; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Index of Microcirculatory Resistance (IMR) after IVL

  through study completion, an average of 1 year

Secondary Outcomes (2)

• 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

Study Arms (1)

Single arm

EXPERIMENTAL

single arm intervention with IVL in calcified de novo coronary stenoses with indication of plaque modification technique during PCI

Device: Shockwave® Intravascular Lithotripsy System (Shockwave Medical Inc)

Interventions

Shockwave® Intravascular Lithotripsy System (Shockwave Medical Inc) DEVICE

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.

Single arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Unable to provide written informed consent (IC)
• 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.

Sponsors & Collaborators

• Cardiac Research Institute BV: lead

Study Sites (1)

Hospital San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Carlos Collet

  Cardiovascular Center OLV Aalst

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The MARVEL Pilot STUDY is an investigator-initiated, multicenter, single-arm, open-label, assessing the microcirculation after IVL and PCI in severe calcific stenoses.

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: November 24, 2021
• Study Start: October 6, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)