Coronary Disease Clinical Trial
Official title:
Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
The main objective of the CHANGE registry is the evaluation of the real-world performance and safety profile of the R-One System in PCI.
The R-One system is a class "IIb" CE marked medical device designed to remote deliver and manipulate coronary guidewires and stent/balloon devices during Percutaneous Coronary Intervention (PCI). The system comprises the R-One Robotic Platform used in combination with two accessories, the Mobile Radioprotection Screen and a sterile and single-use R-One Consumable Kit. The R-One is not autonomous and operates only under the operator's commands. This study is a single-arm, open-label, multi-center registry. The CHANGE registry, part of the ROBOCATH's post-market clinical follow-up activities, is a real world study aiming to confirm the safety and performance, including the clinical benefit, of the R-One robotic systems medical device. 500 patients with coronary artery disease and with clinical indication for PCI will be recruited in up to Up to 15 centers distributed in Europe and South Africa. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
| Completed |
NCT05672862 -
International Post-PCI FFR Extended Registry
|
||
| Completed |
NCT04492423 -
VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study
|
||
| Completed |
NCT01205776 -
EXCEL Clinical Trial
|
N/A | |
| Recruiting |
NCT01218776 -
International Survey of Acute Coronary Syndromes in Transitional Countries
|
||
| Completed |
NCT00046410 -
Comparison of the Risk of Stroke With On- Versus Off-Pump Coronary Artery Bypass Grafting
|
N/A | |
| Recruiting |
NCT04390672 -
Multivessel TALENT
|
N/A | |
| Completed |
NCT02784873 -
High Intensity Interval Training in UK Cardiac Rehabilitation Programmes
|
N/A | |
| Not yet recruiting |
NCT02895009 -
Hemostatic Compression Patterns After Transradial Coronary Intervention
|
N/A | |
| Completed |
NCT02948517 -
Time Restricted Feeding for Weight Loss and Cardio-protection
|
N/A | |
| Recruiting |
NCT02859480 -
Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI
|
Phase 4 | |
| Withdrawn |
NCT02418143 -
A Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope
|
||
| Completed |
NCT02382731 -
Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction
|
N/A | |
| Completed |
NCT02510547 -
Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
|
Phase 4 | |
| Recruiting |
NCT01681381 -
Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization
|
N/A | |
| Completed |
NCT02248415 -
Administration of Warm Blood Cardioplegia With or Without Roller Pump
|
N/A | |
| Recruiting |
NCT01207167 -
Mediators of Atherosclerosis in South Asians Living in America
|
||
| Completed |
NCT02088138 -
Functional Electrical Stimulation in Cardiac Patients
|
N/A | |
| Completed |
NCT02173067 -
Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective
|
N/A | |
| Completed |
NCT02133807 -
Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis
|
Phase 3 |