Calcium Reduction by Orbital Atherectomy in Western Europe (CROWN)

Erasmus University

Status: Enrolling

Conditions: Coronary Angiography; Coronary Intervention, Percutaneous; Vascular Calcification* / Therapy; Humans; Vascular Calcification; Atherectomies, Coronary; Treatment Outcome; Tomography, Optical Coherence; Vascular Calcification* / Diagnostic Imaging

Treatments: Device: Orbital Atherectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06035783

NL81318.078.22

Details and patient eligibility

About

In calcified lesions, optimal stent placement and expansion may prove to be challenging. Lesion preparation is necessary to facilitate optimal stenting in calcified lesions, for which orbital atherectomy can used. Therefore the aim of this study is to:

1. Show that orbital atherectomy effectuates optimal stent expansion
2. Investigate the mechanics of lesion preparation when using orbital atherectomy

Patients presenting with a significant and severely calcified lesion in need of orbital atherectomy will undergo optical coherence tomography guided orbital atherectomy and stent placement.

Full description

The Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems Inc., St. Paul,MN,USA) is a percutaneous device indicated to modify calcified lesion in order to facilitate stent delivery in patients with severely calcified coronary artery disease (CAD). As of to date, detailed sequential intravascular imaging data unraveling the exact calcium modifying effect of orbital atherectomy (OA) prior to stent placement in vivo, are lacking.

The aim of this, international, multicenter, prospective and observational single arm study is to understand the mechanism of action of OA for the treatment of de novo, severely calcified coronary lesions priot to stent placement using optical coherence tomography (OCT) and to assess stent expansion, based on OCT derived minimal stent area. The study population consists of patients undergoing percutaneous coronary intervention of a severely calcified coronary lesion in need of OA to enable proper stent placement and expansion.

A total of 100 patients will be enrolled. All patients will undergo peri-procedural imaging using OCT and the aim is to obtain data for at least 50 patients with OCT before and after OA and after stenting.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• De novo significant native coronary artery lesion
• The target lesion must have evidence of severe calcification: 1) presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall with calcification length of at least 15 mm and extend partially into the target lesion. 2) OR presence of ≥ 270° of calcium or lumen protruding calcified nodules at >1 cross section by intravascular imaging (OCT)
• The target vessel reference diameter ≥ 2.5 mm and ≤ 4.0 mm and lesion must not exceed 40 mm in length

Exclusion criteria

• Left main disease
• Prior stenting of the target vessel
• Target lesion has thrombus or dissection
• Known left ventricular ejection fraction LVEF ≤ 25%
• Diagnosed with chronic renal failure (GFR < 30 ml/min)
• Confirmed pregnancy
• Life expectancy < 12 months
• Coronary anatomy that prevents delivery of OCT catheter
• Known allergy to soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide

Trial design

100 participants in 1 patient group

Observational cohort

Description:

Patients undergoing PCI of a severely calcified coronary lesion in need of OA to enable proper stent placement

Treatment:

Device: Orbital Atherectomy