Calcium Reduction by Orbital Atherectomy in Western Europe: the CROWN study

Calcium Reduction by Orbital Atherectomy in Western Europe: the CROWN study - CROWN

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51361

Enrollment

Registered

2022-06-10

Start date

2024-03-07

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcified coronary lesions Calcified coronary lesions

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. De novo significant native coronary artery lesion. 2. The target lesion must have evidence of severe calcification: a. 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. b. Presence of >=270° of calcium or lumen protruding calcified nodule(s) at >1 cross section assessed by OCT. 3. The target vessel reference diameter >= 2.5 mm and 18 years or minimum age as required by local regulations

Exclusion criteria

Exclusion criteria: 1. Left main disease 2. Prior stenting of the target vessel. 3. Target lesion has thrombus or dissection. 4. Known LVEF

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is proportion of patients with stent expansion defined by OCT derived minimal stent area (MSA) >= 5.5mm².	—

Secondary

Measure	Time frame
Secondary endpoint Divided into three subgroups, clinical, intracoronary imaging and angiographic endpoints. Clinical endpoints (measured at discharge, 30 days and 12 months): • Procedural success, defined as successful stent delivery with: o Final Core Lab defined Thrombolysis in Myocardial Infarction (TIMI) flow of III. o Angiographic in-stent diameter stenosis (DS) <=20%. o Absence of in-hospital major adverse cardiac and cerebrovascular events (MACCE, consisting of all-cause death, spontaneous myocardial infarction (MI), target vessel revascularization (TVR), stroke). • Target vessel failure (TVF, consisting of cardiac death, target vessel spontaneous MI, and TVR). • Major adverse cardiac events (MACE, consisting of all-cause death, spontaneous MI, and repeat revascularization). • Individual components of MACE and TVF. • Incidence of periprocedural MI: o Type 4a (4th universal def). • Major angiographic intraprocedural complications including type C-F dissections, perforations, persistent slow flow or persistent no reflow, thrombus and major side branch occlusion (>2mm). • Probable and definite stent thrombosis• Need for renal replacement at 30 days Intracoronary imaging endpoints (OCT) • Final MSA • Percentage of stent expansion • Percentage of lumen area gain post OA and post stenting • Minimal lumen area (MLA) post OA and post stenting • Number of calcium fractures • Number of calcium fractures based on calcium thickness post OA • Incidence of OCT defined hematomas post OA • Incidence and quantification of dissections post OA • Number of calcified nodules modified post OA Angiographic endpoints (Core Lab Assessed): • Lesion length, diameter percentage of stenosis, reference vessel diameter • In-stent and in-segment DS • In-stent and in-segment minimal lumen diameter (MLD) • In-stent and in-segment acute gain	—

Measure

Time frame

Secondary endpoint Divided into three subgroups, clinical, intracoronary imaging and angiographic endpoints. Clinical endpoints (measured at discharge, 30 days and 12 months): • Procedural success, defined as successful stent delivery with: o Final Core Lab defined Thrombolysis in Myocardial Infarction (TIMI) flow of III. o Angiographic in-stent diameter stenosis (DS) <=20%. o Absence of in-hospital major adverse cardiac and cerebrovascular events (MACCE, consisting of all-cause death, spontaneous myocardial infarction (MI), target vessel revascularization (TVR), stroke). • Target vessel failure (TVF, consisting of cardiac death, target vessel spontaneous MI, and TVR). • Major adverse cardiac events (MACE, consisting of all-cause death, spontaneous MI, and repeat revascularization). • Individual components of MACE and TVF. • Incidence of periprocedural MI: o Type 4a (4th universal def). • Major angiographic intraprocedural complications including type C-F dissections, perforations, persistent slow flow or persistent no reflow, thrombus and major side branch occlusion (>2mm). • Probable and definite stent thrombosis• Need for renal replacement at 30 days Intracoronary imaging endpoints (OCT) • Final MSA • Percentage of stent expansion • Percentage of lumen area gain post OA and post stenting • Minimal lumen area (MLA) post OA and post stenting • Number of calcium fractures • Number of calcium fractures based on calcium thickness post OA • Incidence of OCT defined hematomas post OA • Incidence and quantification of dissections post OA • Number of calcified nodules modified post OA Angiographic endpoints (Core Lab Assessed): • Lesion length, diameter percentage of stenosis, reference vessel diameter • In-stent and in-segment DS • In-stent and in-segment minimal lumen diameter (MLD) • In-stent and in-segment acute gain

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Countries

Germany, Italy, Netherlands

Contacts

Public ContactW.K. Dekker

Erasmus MC, Universitair Medisch Centrum Rotterdam

w.dendekker@erasmusmc.nl010-7035260

Outcome results