NCT04556682

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Calcification

Interventions

Type	Name	Description
DEVICE	Rotational atherectomy	Device used for severely calcified coronary lesion preparation before stent implantation.
DEVICE	Intravascular lithotripsy	Device used for severely calcified coronary lesion preparation before stent implantation.

Timeline

• Start date: 2021-05-01
• Primary completion: 2021-12-15
• Completion: 2022-02-25
• First posted: 2020-09-21
• Last updated: 2022-08-02

Locations

1 site across 1 country: Netherlands