The ROB-OSTIAL Study

Status Terminated

Clinical Trial Summary

The purpose of this study is to compare the accuracy of robotic-assisted percutaneous coronary intervention (PCI) using the CorPath GRX® System, versus standard PCI when treating ostial lesions. CorPath GRX System (the Device) is a robotic-like device that is cleared for the remote delivery and control of heart catheterization devices. It helps doctors insert and move heart catheters (a thin, flexible tube) and similar types of devices inside patients blood vessels to treat the blockage in their heart. The results will help to evaluate whether procedures using the CorPath GRX result in more accurate stenting (placing of a tube to keep heart vessel open) compared to standard PCI.

Clinical Trial Description

To assess accuracy of robotic-assisted PCI in obtaining full ostial lesion coverage and minimal protrusion compared to standard PCI. Robotically assisted PCI offers the opportunity of performing minimal device movements (up to a minimum of 1 mm) in a stable and reproducible setting. This feature may be of great help when dealing with ostial lesions, whose treatment requires a precise stent positioning to avoid strut protrusion but also geographic miss of the lesion. Robotic-assisted PCI for ostial lesions showed encouraging results in large observational registries, but no study compared this approach with standard PCI. The aim is to perform a randomized (1:1) study comparing standard (n=33) and robotic-assisted PCI (n=33) in obtaining full lesion coverage when treating ostial lesions (ostial left main will be excluded). Primary endpoint of the study will be full ostial coverage as assessed by IVUS imaging, while secondary endpoints will be procedural success, vessel damage and number of protruding struts in the donor vessel as assessed by IVUS imaging. ;

Study Design

Related Conditions & MeSH terms

Coronary Artery Disease

Clinical Trial Details

NCT number	NCT05634538
Study type	Interventional
Source	Corindus Inc.
Contact
Status	Terminated
Phase	N/A
Start date	March 30, 2023
Completion date	May 8, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06030596` - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed	`NCT04080700` - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting	`NCT03810599` - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study	N/A
Recruiting	`NCT06002932` - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.	N/A
Not yet recruiting	`NCT06032572` - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)	N/A
Recruiting	`NCT04242134` - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions	N/A
Recruiting	`NCT05308719` - Nasal Oxygen Therapy After Cardiac Surgery	N/A
Completed	`NCT04556994` - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.	N/A
Recruiting	`NCT05846893` - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease	N/A
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Recruiting	`NCT05023629` - STunning After Balloon Occlusion	N/A
Completed	`NCT04941560` - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed	`NCT04006288` - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease	Phase 4
Completed	`NCT01860274` - Meshed Vein Graft Patency Trial - VEST	N/A
Recruiting	`NCT06174090` - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients	N/A
Completed	`NCT03968809` - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated	`NCT03959072` - Cardiac Cath Lab Staff Radiation Exposure
Recruiting	`NCT04566497` - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.	N/A
Recruiting	`NCT05065073` - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography	Phase 4
Completed	`NCT05096442` - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions	N/A