Calcium Reduction by Orbital Atherectomy in Western Europe (CROWN)

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Calcification; Tomography, Optical Coherence; Treatment Outcome; Coronary Angiography; Humans; Vascular Calcification* / Diagnostic Imaging; Atherectomies, Coronary; Coronary Intervention, Percutaneous; Vascular Calcification* / Therapy
• Intervention / Treatment: Device: Orbital Atherectomy

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015GE
      • Recruiting
      • Erasmus Medical Center
      • Contact: wijnand den Dekker, MD, PhD; Phone Number: +31645184272; Email: w.dendekker@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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; Other Names: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Procedural success is defined as successful stent delivery with: Final core lab defined TIMI III flow; Angiographic in-stent DS ≤20%; absence of in-hospital major adverse cardiac and cerebrovascular events (consisting of all-cause death, spontaneous myocardial infarction, target vessel revascularization or stroke)	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Target vessel failure (TVF)	TVF is defined as a composite of cardiac death, target vessel spontaneous myocardial infarction and target vessel revascularization.	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)	MACE is defined is a composite of all-cause death, spontaneous myocardial infarction and repeat revascularization	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	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	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	The incidence of periprocedural myocardial infarction, namely type 4a (4th universal definition of myocardial infarction)	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Major intraprocedural complications	Major intraprocedural complications include type C-F dissections, perforations, slow flow or no reflow, thrombus and major side branch occlusion (> 2mm)	Periprocedure
Probable and definite stent thrombosis		Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months
MSA on OCT	Final MSA	Periprocedure
Stent expansion on OCT	Percentage of stent expansion	Periprocedure
Intracoronary imaging endpoints on OCT	Minimal lumen area post orbital atherectomy and post stenting	Periprocedure
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	Periprocedure
Hematoma on OCT	Incidence of OCT defined hematomas post orbital atherectomy; Incidence and quantifications of dissections post orbital atherectomy	Periprocedure
Diameter stenosis on angiography	- In-stent and in-segment DS	Periprocedure
minimal luminal diameter Diameter on angiography	- In-stent and in-segment MLD	Periprocedure
Acute gain Diameter on angiography	- In-stent and in-segment acute gain	Periprocedure

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis; Vascular Calcification
• Other Study ID Numbers: NL81318.078.22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes