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Calcium Reduction by Orbital Atherectomy in Western Europe

NCT06035783 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-02-29

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

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

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2025-04-01
Completion
2025-04-01
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06035783 on ClinicalTrials.gov