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Vascular Calcification* / Diagnostic ImagingCROWNNCT06035783

Calcium Reduction by Orbital Atherectomy in Western Europe

An observational study of Vascular Calcification* / Diagnostic Imaging and Atherectomies, Coronary, run by Erasmus Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Orbital Atherectomy
Type of treatment
Medical device
How many people
100 participants
Where
1 siteNetherlands
Study dates
15 Mar 2024to 1 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

1 site in 1 country.

Netherlands1 site, 1 recruiting

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015GE

    wijnand den Dekker, MD, PhD, +31645184272, w.dendekker@erasmusmc.nl

    Recruiting

Other trials in Netherlands

About this study

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.

Read the 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.

Being tested
Orbital Atherectomy
Medical subject headings
Vascular Calcification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orbital AtherectomyDevice

    Also called DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    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

Study groups in NCT06035783
Study groupRoleWhat they receive
Observational cohortPatients undergoing PCI of a severely calcified coronary lesion in need of OA to enable proper stent placement
Receives: Device: Orbital Atherectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary imaging endpoint

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

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

Secondary outcomes (15)

  1. Procedural success

    Procedural success is defined as successful stent delivery with:

    1. Final core lab defined TIMI III flow
    2. Angiographic in-stent DS ≤20%
    3. absence of in-hospital major adverse cardiac and cerebrovascular events (consisting of all-cause death, spontaneous myocardial infarction, target vessel revascularization or stroke)

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

  2. Target vessel failure (TVF)

    TVF is defined as a composite of cardiac death, target vessel spontaneous myocardial infarction and target vessel revascularization.

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

  3. Major adverse cardiac events (MACE)

    MACE is defined is a composite of all-cause death, spontaneous myocardial infarction and repeat revascularization

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

  4. Individual components of MACE and TVF

    The components of MACE and TVF will be measured individually, namely:

    • All-cause death
    • Cardiac death
    • Spontaneous myocardial infarction
    • Target vessel spontaneous myocardial infarction
    • Target vessel revascularization
    • Repeat revascularization

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

  5. Periprocedural myocardial infarction

    The incidence of periprocedural myocardial infarction, namely type 4a (4th universal definition of myocardial infarction)

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

  6. Major intraprocedural complications

    Major intraprocedural complications include type C-F dissections, perforations, slow flow or no reflow, thrombus and major side branch occlusion (> 2mm)

    Measured: Periprocedure

  7. Probable and definite stent thrombosis

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

  8. MSA on OCT

    Final MSA

    Measured: Periprocedure

  9. Stent expansion on OCT

    Percentage of stent expansion

    Measured: Periprocedure

  10. Intracoronary imaging endpoints on OCT

    Minimal lumen area post orbital atherectomy and post stenting

    Measured: Periprocedure

  11. Calcium and fractures on OCT

    • Number of calcium fractures
    • Number of calcium factures based on calcium thickness post orbital atherectomy
    • Number of calcified nodules modified post orbital atherectomy

    Measured: Periprocedure

  12. Hematoma on OCT

    • Incidence of OCT defined hematomas post orbital atherectomy
    • Incidence and quantifications of dissections post orbital atherectomy

    Measured: Periprocedure

  13. Diameter stenosis on angiography

    • In-stent and in-segment DS

    Measured: Periprocedure

  14. minimal luminal diameter Diameter on angiography

    • In-stent and in-segment MLD

    Measured: Periprocedure

  15. Acute gain Diameter on angiography

    • In-stent and in-segment acute gain

    Measured: Periprocedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start15 Mar 2024 (estimated)
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06035783
Sponsor's protocol ID
NL81318.078.22
Acronym
CROWN
Status last verified
Sep 2023
First submitted
10 Mar 2023
Last updated
29 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Ntantou E, Siskos AA, van Mieghem NM, Daemen J, Kardys I, Teeuwen K, Secco GG, Sinning JM, Forlani D, den Dekker WK. Optical coherence tomography-guided orbital atherectomy for calcified coronary lesions: rationale and design of the CROWN study. Neth Heart J. 2026 Aug 4. doi: 10.1007/s12471-026-02055-5. Online ahead of print.

    PubMed 42550426

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Calcification* / Diagnostic Imaging and Atherectomies, Coronary, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary imaging endpoint (time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06035783, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.

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