Calcium Reduction by Orbital Atherectomy in Western Europe

NCT ID: NCT06035783

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2025-04-01

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational cohort

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

Orbital Atherectomy

Intervention Type: DEVICE

The Diamondback 360° Coronary orbital atherectomy system (OAS) is a device dedicated to debulk severely calcified coronary lesions to facilitate stent delivery and enable stent expansion with optimal results. The OAS's main mechanism is the synergistic rotation of the crown around its axis and simultaneously its endoluminal orbital motion. This effect allows blood to flow continuously and it facilitates heat dispersion which results in reduced heat damage to the arterial walls and subsequently to less myocardial damage, at the same time it softens the plaques tissue. It also appears that the microparticles created from sanding the artery plaques do not create any agglomeration to the branching arteries

Interventions

Orbital Atherectomy

The Diamondback 360° Coronary orbital atherectomy system (OAS) is a device dedicated to debulk severely calcified coronary lesions to facilitate stent delivery and enable stent expansion with optimal results. The OAS's main mechanism is the synergistic rotation of the crown around its axis and simultaneously its endoluminal orbital motion. This effect allows blood to flow continuously and it facilitates heat dispersion which results in reduced heat damage to the arterial walls and subsequently to less myocardial damage, at the same time it softens the plaques tissue. It also appears that the microparticles created from sanding the artery plaques do not create any agglomeration to the branching arteries

Intervention Type: DEVICE

Other Intervention Names

DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Wijnand den Dekker

Interventional Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

wijnand den Dekker, MD, PhD

Role: primary

w.dendekker@erasmusmc.nl

+31645184272

Other Identifiers

NL81318.078.22

Identifier Type: -

Identifier Source: org_study_id