NCT05394649

Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ICARE trial will aim to assess the efficacy of rotational atherectomy by Rotablator and Intravascular Lithotripsy by C2 Shockwave Medical® (IVL) in a randomized fashion in highly calcified lesions measured by final minimal stent area (MSA) on Optical Frequency Domain Imaging (OFDI). The investigator hypothesize that there will be no significant difference in final MSA in OFDI between the two groups after angioplasty with a last generation drug eluting stent ULTIMASTER TANSEI.

Detailed description

Calcified coronary lesions will increase in daily percutaneous coronary intervention regarding the significant epidemiological increase of factors leading to coronary calcifications, such as hypertension, aging, and diabetes. Furthermore, calcified lesions are underdiagnosed in angiography as shown by intra-coronary imaging studies (either by OCT or IVUS), which reported that significant calcium deposits might be present in 76-83% of lesions. Calcified lesions are associated with a larger amount of periprocedural complications, as well as a poorer clinical prognosis. Standard techniques to prep the calcified plaque, such as rotational or orbital atherectomy, still have low penetration and are associated with an increase in periprocedural complications without clear clinical evidence of efficacy. More recently, there has been a growing interest in intravascular lithotripsy (IVL), which appears as an appealing option with recently published data with evidence for a safe procedure but without robust data on efficacy (sample size population, debatable effectiveness endpoint…). Although the European Society of Cardiology highlights in the latest myocardial revascularization guidelines the need for lesion preparation before stent implantation on short- and long-term clinical outcomes, no specific recommendation has been given on the use of the dedicated devices to prepare the plaque, including atherectomy, which is left to the operator assessment.

Conditions

• Intravascular Lithotripsy; Rotational Atherectomy; OFDI

Interventions

Type	Name	Description
DEVICE	Intravascular Lithotripsy	A new device has been designed by Shockwave Medical Inc. for the treatment of calcified vascular lesions to support stent delivery: the "C2 Shockwave Medical® (IVL), Inc. coronary lithotripsy system". The system is based on lithotripsy to induce microfractures in the calcified plaque before low-pressure balloon dilation. The C2 Shockwave Medical® coronary lithotripsy (IVL) system consists of an IVL Catheter with two lithotripsy emitters enclosed within an integrated balloon, an IVL Generator, and an IVL Connector Cable.
DEVICE	Rotational Atherectomy	Rotational Atherectomy is a technique of calcic coronary plaque preparation based on the debulking of superficial calcium by a high-speed burr in order to improve vessel compliance and immediate vessel lumen gain before stenting.

Timeline

• Start date: 2022-08-04
• Primary completion: 2024-05-31
• Completion: 2025-05-31
• First posted: 2022-05-27
• Last updated: 2022-08-10

Locations

17 sites across 1 country: France