Atherectomy vs Intravascular Lithotripsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Comparison of Rotational Atherectomy vs INtravascular Lithotripsy for Plaque Modification Before Stent implantatiOn in Patients With Severely Calcified Coronary Lesions: The RAINBOW Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Rotational atherectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotational atherectomy<br>Patients will undergo rotational atherectomy | Diagnostic Test: Rotational atherectomy<br>* Rotational atherectomy<br>|
| Experimental: Intravascular lithotripsy<br>Patients will undergo intravascular lithotripsy | Diagnostic Test: Rotational atherectomy<br>* Rotational atherectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | The time to first occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical coherence tomography (OCT) | The acute lumen gain as assessed by OCT in the two groups | Up to 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, calcium, percutaneous coronary intervention