Atherectomy vs Intravascular Lithotripsy

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: Rotational atherectomy

• Registration Number: NCT04013906
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-07
• Study First Submitted QC: 2019-07-07
• Last Update Submitted: 2019-07-09
• Study First Posted: 2019-07-10
• Last Update Posted: 2019-07-12
• Study Start: 2019-09-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotational atherectomy	Rotational atherectomy	Patients will undergo rotational atherectomy
Intravascular lithotripsy	Rotational atherectomy	Patients will undergo intravascular lithotripsy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Optical coherence tomography (OCT)	Up to 1 day	The acute lumen gain as assessed by OCT in the two groups