Atherectomy vs Intravascular Lithotripsy (RAINBOW)

University of Roma La Sapienza

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: Rotational atherectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04013906

2019/D/389

Details and patient eligibility

About

Preliminary experiences show that IVL is promising for achieving an effective plaque modification at time of PCI.

However, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no randomized comparisons between rotational atherectomy and intravascular lithotripsy have been carried out so far.

The aim of this pilot randomized trial is to evaluate the efficacy and safety of intensive plaque modification with rotational atherectomy vs. intravascular lithotripsy before placement of a drug-eluting stent.

Full description

Calcification of the coronary lesion is challenging during percutaneous coronary intervention (PCI) since it can cause the balloon dilation to fail with subsequent incomplete and asymmetrical stent expansion. Also, calcified coronary lesions are associated with increased risk of adverse events after PCI, such as stent restenosis and thrombosis.

Several devices and techniques have been proposed to treat severely calcified coronary lesions. For many years, modification of these lesions with rotational atherectomy has been considered the gold standard to ease the process of angioplasty and PCI. Recently, intravascular lithotripsy (IVL) has been proposed as an alternative to rotational atherectomy for the treatment of calcified de-novo coronary lesions. The Shockwave Medical Coronary Rx Intravascular Lithotripsy (IVL) System (Shockwave Medical Inc., Fremont, California, USA) is a novel balloon catheter-based device able to disrupt calcified lesions using technology like lithotripsy for kidney stones. Preliminary experiences show that IVL is promising for achieving an effective plaque modification at time of PCI.

However, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no randomized comparisons between rotational atherectomy and intravascular lithotripsy have been carried out so far.

The aim of this pilot randomized trial is to evaluate the efficacy and safety of intensive plaque modification with rotational atherectomy vs. intravascular lithotripsy before placement of a drug-eluting stent.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Reference vessel diameter of 2.5-4.0 mm and lesion lengths of 40 mm or less involving a de novo coronary stenosis.
• Vessel calcification must be severe angiographically as evidenced by calcium present on both sides of the vessel and extending ≥15 mm or by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) with presence of a calcium arc ≥270° in at least one cross-section.
• Calcifications should not be unable to cross with a balloon

Exclusion criteria

• Patients with acute coronary syndromes

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Rotational atherectomy

Experimental group

Description:

Patients will undergo rotational atherectomy

Treatment:

Diagnostic Test: Rotational atherectomy

Intravascular lithotripsy

Experimental group

Description:

Patients will undergo intravascular lithotripsy

Treatment:

Diagnostic Test: Rotational atherectomy