Calcium Reduction by Orbital Atherectomy in Western Europe

Erasmus Medical Center100 enrolled

Overview

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.

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

100

Conditions

Vascular Calcification* / Diagnostic Imaging Atherectomies, Coronary

Interventions

Orbital AtherectomyDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary imaging endpoint

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

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

Secondary Outcomes

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)

Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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)

Time frame: Periprocedure

Probable and definite stent thrombosis

Time frame: 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

Time frame: Periprocedure

Stent expansion on OCT

Percentage of stent expansion

Time frame: Periprocedure

Intracoronary imaging endpoints on OCT

Minimal lumen area post orbital atherectomy and post stenting

Time frame: 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

Time frame: Periprocedure

Hematoma on OCT

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

Time frame: Periprocedure

Diameter stenosis on angiography

\- In-stent and in-segment DS

Time frame: Periprocedure

minimal luminal diameter Diameter on angiography

\- In-stent and in-segment MLD

Time frame: Periprocedure

Acute gain Diameter on angiography

\- In-stent and in-segment acute gain

Time frame: Periprocedure

Calcium Reduction by Orbital Atherectomy in Western Europe

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes