Calcium Reduction by Orbital Atherectomy in Western Europe

NCT06035783 | Unknown FDA Device

• 1 other identifier: NL81318.078.22
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Primary imaging endpoint

  Proportion of patients that reach stent expansion ≥ 5.5mm² as assessed by OCT derived MSA

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

Secondary Outcomes (15)

• Procedural success

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

• Target vessel failure (TVF)

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months

• Major adverse cardiac events (MACE)

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months

• Individual components of MACE and TVF

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months

• Periprocedural myocardial infarction

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

Study Arms (1)

Observational cohort

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

Device: Orbital Atherectomy

Interventions

Orbital Atherectomy 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

Also known as: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing PCI of severely calcified coronary lesion in need of orbital atherectomy to enable proper stent placement and expansion

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GE, Netherlands

RECRUITING

MeSH Terms

Conditions

Vascular Calcification

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: September 13, 2023
• Study Start: March 15, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 29, 2024

Record last verified: 2023-09

Locations

NL (1)