Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06035783
Other study ID # NL81318.078.22
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT01239225 - Prevalence of Abdominal Aortic Aneurysm in Patients Undergoing Coronary Angiography Phase 4
Recruiting NCT05075590 - Coronary Access After Supra-Annular THV Implantation N/A
Completed NCT02606734 - DyeVert Pilot Trial N/A
Completed NCT00632918 - Effects of Heart Rates and Variability of Heart Rates on Image Quality of Dual-Source CT Coronary Angiography N/A
Completed NCT04801901 - Distal Transradial Access for Percutaneous Coronary Intervention N/A
Completed NCT00345501 - Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention Phase 2/Phase 3
Recruiting NCT04521660 - The Effect of Using Virtual Reality Glasses During Coronary Angiography N/A
Completed NCT05982366 - Feasibility and Safety of the Routine Distal Transradial Approach N/A
Recruiting NCT04982419 - Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial Phase 2/Phase 3
Completed NCT00468195 - Optimizing Image Quality in Obese Patients Undergoing Coronary Computed Tomography (CT) Angiography N/A
Completed NCT00468325 - Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT) N/A
Completed NCT04911218 - GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery N/A
Completed NCT04318990 - DIstal vs Proximal Radial Artery Access for Cath N/A
Recruiting NCT06312397 - The Effect on Back Pain and Fatigue Level of Acupressure N/A
Recruiting NCT05319119 - Fractional Flow Reserve Derived From CT Related Treatment
Not yet recruiting NCT05133206 - Fasting or Non-fasting Before Cardiac Catheterization N/A
Completed NCT02818101 - Hypnosis Efficacy for the Prevention of Anxiety During a Coronary Angiography N/A
Completed NCT00465335 - Usefulness of Coronary CT Angiography in Patients With Inconclusive Stress Test Results N/A
Completed NCT04407936 - Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention
Completed NCT05050877 - Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention II