Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT (SCALPO)

July 25, 2023 updated by: Prof. Giuseppe Sangiorgi, University of Rome Tor Vergata
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Rome
      • Roma, Rome, Italy, 00133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients in the Catheterization Laboratory that undergo coronary angiography, are potentially selected.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of stent malapposition after intracoronary lithotripsy application
Time Frame: 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.
five minutes after stent impantation
Incidence of acute vessel dissection and acute stent thrombosis or subacute vessel thrombosis after index procedure
Time Frame: one, six months
Safety endpoint
one, six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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