Clinical trial NCT06035783: Calcium Reduction by Orbital Atherectomy in Western Europe
Official title: Calcium Reduction by Orbital Atherectomy in Western Europe
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vascular Calcification* / Diagnostic Imaging
Atherectomies, Coronary
Tomography, Optical Coherence
Coronary Intervention, Percutaneous
Coronary Angiography
Humans
Treatment Outcome
Vascular Calcification* / Therapy
Vascular Calcification
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary imaging endpoint
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Secondary outcomes:
measure: Procedural success
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Target vessel failure (TVF)
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months
measure: Major adverse cardiac events (MACE)
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months
measure: Individual components of MACE and TVF
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months
measure: Periprocedural myocardial infarction
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Major intraprocedural complications
timeFrame: Periprocedure
measure: Probable and definite stent thrombosis
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months
measure: MSA on OCT
timeFrame: Periprocedure
measure: Stent expansion on OCT
timeFrame: Periprocedure
measure: Intracoronary imaging endpoints on OCT
timeFrame: Periprocedure
measure: Calcium and fractures on OCT
timeFrame: Periprocedure
measure: Hematoma on OCT
timeFrame: Periprocedure
measure: Diameter stenosis on angiography
timeFrame: Periprocedure
measure: minimal luminal diameter Diameter on angiography
timeFrame: Periprocedure
measure: Acute gain Diameter on angiography
timeFrame: Periprocedure
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid Holland
Study officials:
References: