IVL and RA in Treatment of Balloon-crossable Severely Calcified Coronary Lesions

July 30, 2022 updated by: Mohamed Aboelkasem Ali Mousa, Assiut University

Intravascular Lithotripsy and Rotational Atherectomy in Treatment of Severely Calcified Coronary Lesions

This study to compare periprocedural safety, angiographic success as well as short and long term outcomes of intravascular lithotripsy and rotational atherectomy as a method of severely calcified coronary lesion preparation before DES implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coronary artery calcification (CAC) occurs in over 90% of men and 67% of women older than 70 years old .

Severe coronary calcification may be present in about 20% of patients undergoing percutaneous coronary intervention (PCI) .

Coronary calcification may impair stent delivery and expansion and damage the polymer/drug coating, resulting in impaired drug delivery and predispose to restenosis and stent thrombosis.

Intravascular imaging as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are good tools to assess calcium burden, distribution and thickness. Among the two imaging techniques, OCT was found to be more accurate than IVUS in defining calcium burden, calcium area , thickness and calcium length.

Rotational atherectomy (RA) as a method of severely calcified lesions modification before Drug-Eluting-Stent (DES) implantation has shown good outcomes in recent studies. However, its efficacy is reduced in presence of deep calcification.

Recently, intravascular lithotripsy (IVL) has been introduced as a novel modality for severely calcified coronary lesion preparation with good preliminary outcomes .

Currently the two techniques are regularly being used in combination in order to achieve optimal results . Whether IVL is a method equally good (or superior) to rotablation in cases where anatomy does not exclude the use of either technique (for example balloon-crossable, heavily calcified lesions) has not yet been discussed.

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

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

Study Locations

  • Netherlands
      • Leiden, Netherlands
        • Leiden University Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary artery disease who found to have severe coronary calcification during percutaneous coronary intervention.

Description

Inclusion Criteria:

  • Patients aged >18 years undergoing PCI because of stable angina (uncontrolled symptoms on optimal medical treatment) or post stabilized acute coronary syndrome (ACS).
  • Patients have severe calcification: defined either angiographically or by OCT (or IVUS) as calcium arch >180º in at least one cross section , calcium length >5mm, calcium thickness >0.5 mm (2, 6).
  • Vessel diameter ≥2.5mm and ≤4.0mm .
  • Heavily calcified lesion length less than 40mm.
  • All patients must have been discussed in the heart team of the hospital and accepted for coronary intervention

Exclusion Criteria:

  • Severe coronary calcification with lesion uncrossable from a balloon.
  • PCIs in the setting of STEMI or NSTEMI with persistent complains.
  • Patients in cardiogenic shock.
  • Heart failure New York Heart Association (NYHA) class IV.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who underwent Rotational atherectomy (RA)
The device contains rapidly rotating burr that is coated with microscopic diamond chips, which debulks the calcified plaque by grinding the calcified atheroma into small particles facilitating stent passage and expansion. Both transfemoral or transradial approach can be used. Regular PCI guidewire can be used to cross the often complex anatomy then switching to a rotablation dedicated guidewire over a microcatheter. Burr sizes vary from 1.25mm up to 1.75mm (in certain cases bigger calibers may also be used) aiming to achieve plaque modification .
Device: Rotational atherectomy
Device used for severely calcified coronary lesion preparation before stent implantation.
Patients who underwent Intravascular lithotripsy (IVL)
The Coronary IVL System consists of an IVL Balloon Catheter with 2 integrated emitters, a Lithotripsy Generator, and a Connector Cable. These emitters create sonic pressure waves that selectively fracture calcium and alter vessel compliance facilitating stent passage and expansion. It is available in 2.5- to 4.0-mm diameters and 12 mm in length, with an inflation pressure of 4 atm used for delivering the treatment. Every catheter can emit a maximum of 80 pulses at a rate of one pulse per second. The IVL balloon catheter is chosen based on the reference lumen of the vessel and after pre-dilatation of the lesion (preferably with a non-compliant balloon) 10-30 pulses are given, usually with interval deflation to allow distal perfusion. If the lesion exceeds the 12 mm balloon length, the balloon can be repositioned and the IVL repeated .
Device: Intravascular lithotripsy
Device used for severely calcified coronary lesion preparation before stent implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strategy success
Time Frame: Up to one day
less than 20% in-stent residual stenosis of the target lesion and no postprocedural complications as no-reflow, dissection or perforation.
Up to one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events
Time Frame: after one year
composite of Death, stroke, myocardial infarction, stent thrombosis, target vessel revascularization, and hospitalization at long term follow up
after one year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Amr youssef, professor, Assiut University
  • Study Chair: Johan W Jukema, professor, Leiden University Medical Center
  • Study Director: Iannis Karalis, Doctor, Leiden University Medical Center
  • Study Chair: Mohamed Abdelghany, professor, Assiut University
  • Study Chair: Salma M Taha, Lecturer, Assiut University
  • Principal Investigator: Mohamed AA Mousa, Doctor, Assiut University

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

Helpful Links

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)

May 1, 2021

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

February 25, 2022

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 30, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVL and RA in calcificaion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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