Calcium Reduction by Orbital Atherectomy in Western Europe

Coronary Angiography Clinical Trial

— CROWN  

Official title:

Calcium Reduction by Orbital Atherectomy in Western Europe

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035783
• Other study ID #: NL81318.078.22
• Status: Recruiting
• Start date: March 15, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: September 2023
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Coronary Angiography
• Humans
• Tomography, Optical Coherence
• Treatment Outcome
• Vascular Calcification

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	MSA on OCT	Final MSA	Periprocedure
Secondary	Stent expansion on OCT	Percentage of stent expansion	Periprocedure
Secondary	Intracoronary imaging endpoints on OCT	Minimal lumen area post orbital atherectomy and post stenting	Periprocedure
Secondary	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
Secondary	Hematoma on OCT	Incidence of OCT defined hematomas post orbital atherectomy; Incidence and quantifications of dissections post orbital atherectomy	Periprocedure
Secondary	Diameter stenosis on angiography	- In-stent and in-segment DS	Periprocedure
Secondary	minimal luminal diameter Diameter on angiography	- In-stent and in-segment MLD	Periprocedure
Secondary	Acute gain Diameter on angiography	- In-stent and in-segment acute gain	Periprocedure