Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT
NCT ID: NCT05973994
Last Updated: 2023-08-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
30 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-02-21
Study Completion Date
2024-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Coronary Artery Calcification
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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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.
intravascular lithotripsy with Shockwave coronary system
Intervention Type
DEVICE
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.
Interventions
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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.
Intervention Type
DEVICE
Other Intervention Names
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OCT acquisition with FD-OCT imaging catheter
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
100 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Rome Tor Vergata
OTHER
Sponsor Role
lead
Responsible Party
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Prof. Giuseppe Sangiorgi
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Giuseppe M Sangiorgi, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Rome Tor Vergata
Locations
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University of Rome Tor Vergata - Policlinico
Roma, Rome, Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
75/21
Identifier Type: -
Identifier Source: org_study_id
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