Atherectomy vs Intravascular Lithotripsy

Last updated: July 9, 2019
Sponsor: University of Roma La Sapienza
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cardiac Disease

Cardiovascular Disease

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT04013906
2019/D/389
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Reference vessel diameter of 2.5-4.0 mm and lesion lengths of 40 mm or less involvinga de novo coronary stenosis.

  • Vessel calcification must be severe angiographically as evidenced by calcium presenton 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 leastone cross-section.

  • Calcifications should not be unable to cross with a balloon

Exclusion

Exclusion Criteria:

• Patients with acute coronary syndromes

Study Design

Total Participants: 100
Study Start date:
September 01, 2019
Estimated Completion Date:
December 31, 2021

Study 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.