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

Completed

• Conditions: Coronary Calcification
• Interventions: Device: Rotational atherectomy; Device: Intravascular lithotripsy

• Registration Number: NCT04556682
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Study Start: 2021-05-01
• Primary Completion: 2021-12-15
• Study Completion: 2022-02-25
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-30
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who underwent Rotational atherectomy (RA)	Rotational atherectomy	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 .
Patients who underwent Intravascular lithotripsy (IVL)	Intravascular lithotripsy	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 .

Primary Outcome Measures

Name	Time	Method
Strategy success	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.

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	after one year	composite of Death, stroke, myocardial infarction, stent thrombosis, target vessel revascularization, and hospitalization at long term follow up

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands