SCALPO: Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT

Sponsor

University of Rome Tor Vergata (Other)

Overall Status

Recruiting

CT.gov ID

NCT05973994

Collaborator

(none)

Enrollment

Location

28.3

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational, prospective, multicenter study is to explore local action of coronary calcium fragmentation exerted by endovascular lithotripsy by images acquired with OCT, in patients with coronary artery calcifications responsible for significant stenosis, candidate to PCI. The main question it aims to answer, is the ability of Shockwave System to reduce calcium density in the Region of Interest (ROI) of the vessel wall.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Calcification	Device: intravascular lithotripsy with Shockwave coronary system

Detailed Description

Coronary arteries with calcific lesions will undergo intravasculary lithotripsy (IVL) treatment; OCT acquisition will be performed before IVL treatment, after IVL treatment and after stent-implantation. All OCT frames will be uploaded on the image processing and analysis program ImageJ (US National Institutes of Health). ROI will be selected as part of image where calcium is located. Image analysis will be performed using frequency histogram of pixel density in the ROI pre- and post-IVL, as a measure of calcium density. Mean pixel density of the ROI before IVL will be compared with mean pixel density of the ROI after IVL, measuring delta pixel density.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT

Actual Study Start Date :

Feb 21, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients with significant calcific coronary artery stenosis candidate to PCI Patients with coronary artery calcifications responsible for significant stenosis will undergo basal OCT acquistion. After intravascular lithotripsy (IVL) application, a second OCT acquisition will be made. The mean calcium density of the vessel's ROI before IVL and after IVL will be compared. Stent implantation will be performed after the second OCT acquisition.	Device: intravascular lithotripsy with Shockwave coronary system OCT acquistion is performed at baseline. Then the IVL catheter will be passed across the lesion over the guidewire. Atherectomy or cutting/scoring balloons is not permitted per protocol. The IVL procedure is considered successful when a residual stenosis <50% by visual estimate after IVL alone is achieved. After IVL procedure, one OCT imaging acquisition must be performed. If the residual stenosis is ≥50% following IVL, noncompliant balloon dilatation will be performed prior to stenting and OCT images repeated accordingly. Subsequent stent implantation will be performed per local standard of care at the discretion of the operator. Following stent implantation, high pressure post-dilatation is recommended and OCT imaging acquisition must be performed to assess stent apposition for secondary end point. Other Names: OCT acquisition with FD-OCT imaging catheter

Arm

Intervention/Treatment

Patients with significant calcific coronary artery stenosis candidate to PCI

Patients with coronary artery calcifications responsible for significant stenosis will undergo basal OCT acquistion. After intravascular lithotripsy (IVL) application, a second OCT acquisition will be made. The mean calcium density of the vessel's ROI before IVL and after IVL will be compared. Stent implantation will be performed after the second OCT acquisition.

Device: intravascular lithotripsy with Shockwave coronary system

OCT acquistion is performed at baseline. Then the IVL catheter will be passed across the lesion over the guidewire. Atherectomy or cutting/scoring balloons is not permitted per protocol. The IVL procedure is considered successful when a residual stenosis <50% by visual estimate after IVL alone is achieved. After IVL procedure, one OCT imaging acquisition must be performed. If the residual stenosis is ≥50% following IVL, noncompliant balloon dilatation will be performed prior to stenting and OCT images repeated accordingly. Subsequent stent implantation will be performed per local standard of care at the discretion of the operator. Following stent implantation, high pressure post-dilatation is recommended and OCT imaging acquisition must be performed to assess stent apposition for secondary end point.

Other Names:

OCT acquisition with FD-OCT imaging catheter

Outcome Measures

Primary Outcome Measures

Reduction of calcium density in the Region of Interest (ROI) of the vessel after lithotripsy treatment [five-ten minutes]
Calcium density is measured as delta pixel-density between calcific lesions images before and after lithotripsy at OCT acquisition

Secondary Outcome Measures

Reduction of stent malapposition after intracoronary lithotripsy application [five minutes after stent impantation]
Sten malapposition is measured as the distance between the abluminal surface of the strut and the luminal surface of the artery wall in the frames of lesion acquired by OCT after stent implantation.
Incidence of acute vessel dissection and acute stent thrombosis or subacute vessel thrombosis after index procedure [one, six months]
Safety endpoint

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
Left ventricular ejection fraction (LVEF) ≥35% as measured prior to enrollment
eGFR ≥45 ml/min (Cockroft-Gault, MDRD)
Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure or if troponin is elevated, concomitant CK must be normal
Ability to tolerate dual antiplatelet therapy (i.e. aspirin and clopidogrel, prasugrel, or ticagrelor) for at least 6 months (for patient not on oral anticoagulation) and single antiplatelet therapy for life
The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
Single de novo target lesion stenosis of LAD, RCA or LCX (or of their branches) with stenosis of ≥70% and <100% or stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR <0.89 or IVUS or OCT minimum lumen area ≤4.0 mm²
Reference vessel must have 2.5 mm - 4.0 mm diameter and ≤ 30 mm length
Evidence of calcification at the lesion site assessed by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, or by IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
Planned treatment of single lesion for every target vessel
Ability to pass a 0.014" guide wire across the lesion
The target vessel must have a TIMI flow 3 at baseline

Exclusion Criteria:

Left ventricular ejection fraction (LVEF) <35%
Subject is pregnant or nursing
eGFR <45 ml/min (Cockroft-Gault, MDRD) or chronic dialysis
Untreated pre-procedural haemoglobin <9 g/dL or intention to refuse blood transfusions if one should become necessary
Patient has a platelet count <100,000 cells/mm3 or >750,000 cells/mm3
Patient has a known allergy to protocol required medications (clopidogrel, thienopyridines, aspirin, contrast media) that cannot be adequately premedicated
Uncontrolled diabetes defined as a fasting hyperglycaemia >200 mg/dL or HbA1c greater than or equal to 10%
Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
Patient has an active peptic ulcer or active gastrointestinal (GI) bleeding
Patient has a history of coagulopathy
Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
Subjects with a life expectancy of less than 1 year
Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
Stent implantation in the target vessel within the last year or a stent within 10 mm of the target lesion
Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rome Tor Vergata - Policlinico	Roma	Rome	Italy	00133

Sponsors and Collaborators

University of Rome Tor Vergata

Investigators

Principal Investigator: Giuseppe M Sangiorgi, Professor, University of Rome Tor Vergata

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Prof. Giuseppe Sangiorgi, Professor, University of Rome Tor Vergata

ClinicalTrials.gov Identifier:

NCT05973994

Other Study ID Numbers:

75/21

First Posted:

Aug 3, 2023

Last Update Posted:

Aug 3, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Prof. Giuseppe Sangiorgi, Professor, University of Rome Tor Vergata

Coronary artery calcification

Intravascular Lithotripsy

Optical Coherence Tomography

Calcium density

Additional relevant MeSH terms:

Calcinosis

Study Results

No Results Posted as of Aug 3, 2023