Calcium Reduction by Orbital Atherectomy in Western Europe

Recruiting

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

• Registration Number: NCT06035783
• Lead Sponsor: Erasmus Medical Center

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. 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.

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 Timeline

• Study First Submitted: 2023-03-10
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-13
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Study Start: 2024-03-15
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational cohort	Orbital Atherectomy	Patients undergoing PCI of a severely calcified coronary lesion in need of OA to enable proper stent placement

Primary Outcome Measures

Name	Time	Method
Primary imaging endpoint	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours	Proportion of patients that reach stent expansion ≥ 5.5mm² as assessed by OCT derived MSA

Secondary Outcome Measures

Name	Time	Method
Diameter stenosis on angiography	Periprocedure	- In-stent and in-segment DS
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	TVF is defined as a composite of cardiac death, target vessel spontaneous myocardial infarction and target vessel revascularization.
Intracoronary imaging endpoints on OCT	Periprocedure	Minimal lumen area post orbital atherectomy and post stenting
Major intraprocedural complications	Periprocedure	Major intraprocedural complications include type C-F dissections, perforations, slow flow or no reflow, thrombus and major side branch occlusion (\> 2mm)
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
Procedural success	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours	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)
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	MACE is defined is a composite of all-cause death, spontaneous myocardial infarction and repeat revascularization
MSA on OCT	Periprocedure	Final MSA
Stent expansion on OCT	Periprocedure	Percentage of stent expansion
Calcium and fractures on OCT	Periprocedure	* Number of calcium fractures; * Number of calcium factures based on calcium thickness post orbital atherectomy; * Number of calcified nodules modified post orbital atherectomy
Hematoma on OCT	Periprocedure	* Incidence of OCT defined hematomas post orbital atherectomy; * Incidence and quantifications of dissections post orbital atherectomy
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	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
Periprocedural myocardial infarction	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours	The incidence of periprocedural myocardial infarction, namely type 4a (4th universal definition of myocardial infarction)
minimal luminal diameter Diameter on angiography	Periprocedure	- In-stent and in-segment MLD
Acute gain Diameter on angiography	Periprocedure	- In-stent and in-segment acute gain

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid Holland, Netherlands