Atherectomy vs Intravascular Lithotripsy

Coronary Artery Disease Clinical Trial

— RAINBOW  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04013906
• Other study ID #: 2019/D/389
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2019
• Source: University of Roma La Sapienza
• Contact: Francesco Pelliccia
• Phone: +390633062615
• Email: f.pelliccia[@]mclink.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Rotational atherectomy
Rotational atherectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Optical coherence tomography (OCT)	The acute lumen gain as assessed by OCT in the two groups	Up to 1 day