Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: Guiding Catheter: Guiding Catheter Used to record intra cardiac pressures, to sample blood, and to introduce substances into the heart and vessels.
Control Intervention1: NA: NA
Sponsors
Newtech Medical Devices Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 years or older. Male and female Subjects scheduled for diagnostic or interventional cardiovascular procedures eg angiography, PCI where the use of a guiding catheter is clinically indicated. 2.Subjects able to provide written informed consent before any study specific procedures. 3.Subjects who are hemodynamically stable and suitable for catheter-based vascular access. 4.Target vessel anatomy is appropriate for catheter navigation and guide placement based on pre-procedural imaging. Willing and able to comply with protocol requirements, including a 7day follow-up.
Exclusion criteria
Exclusion criteria: 1.Known allergy or hypersensitivity to materials used in the guiding catheter eg polymer coating, EO sterilization residuals. 2.Severe peripheral vascular disease, tortuous anatomy, or calcified vessels that may compromise safe catheter introduction or tracking. 3.Participation in another investigational study within the last 30 days that may interfere with this investigation. 4.Active systemic infection or localized infection at the planned vascular access site. 5.Pregnant or breastfeeding women, unless the procedure is clinically necessary and ethically justified. 6.Subjects with known coagulation disorders or on anticoagulant therapy that poses increased procedural risk. 7.Significant anatomical abnormalities eg aneurysm, severe aortic arch angulation that may preclude safe catheter navigation. 8.Life expectancy less than 30 days due to underlying non-cardiac illnesses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural Success Rate: Successful vascular access, device delivery, and contrast injection without catheter-related failure. Device-Related Adverse Events (within 7 days): No major complications such as dissection, perforation, vasospasm, embolism, hematoma, or catheter malfunction. Timepoint: Pre-operative, Operative, Day2, Day7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Usability Investigator feedback on insertion, navigation, torque control, kink resistance, visibility. 2.Technical Issues Any problems like flushing difficulty, incompatibility, or need for catheter replacement. 3.Fluoroscopy Compatibility: Adequate visibility compatibility with common devices stents, balloons, wires. Workflow Impact Any delays or procedural issues due to catheter performance. Timepoint: Pre-operative, Operative, Day2, Day 7 | — |
Countries
India
Contacts
Public ContactMr Praveen Shukla
Newtech Medical Devices PVT LTD
Outcome results
None listed