Coronary Angiography Clinical Trial
Official title:
Calcium Reduction by Orbital Atherectomy in Western Europe
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. ;
| 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 |
NCT00468325 -
Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)
|
N/A | |
| Completed |
NCT00468195 -
Optimizing Image Quality in Obese Patients Undergoing Coronary Computed Tomography (CT) Angiography
|
N/A | |
| Completed |
NCT04911218 -
GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery
|
N/A | |
| Recruiting |
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
|