A prospective study to evaluate the safety and performance of a Angiographic catheter Diagnostic catheter in Angiographic procedures
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- POLY MEDICURE LIMITED
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- The primary outcome of the study is the performance of the diagnostic catheter during angiographic procedures. This includes catheter should facilitate smooth and successful navigation through the blood vessels, ensuring stable positioning for angiographic imaging Additionally, it should enable effective contrast injection, providing clear imaging for accurate diagnosis of vascular lesions and determining the need for PTCA.
Study Overview
Brief Summary
Product Name:Angiographic Catheter (Diagnostic Catheter)
Study Design:This is a prospective, single-center, interventional clinical investigation designed to assess the safety and performance of the diagnostic catheter in angiography, enrolling 73 subjects.
Eligible subjects will provide informed consent and baseline clinical data will be recorded. Pre-procedure assessments will include vital signs, a review of medical history and a vascular access evaluation. The catheter will be inserted in accordance with institutional guidelines, navigated to the target vessel, and used for contrast injection and angiographic imaging. Post-procedure, subject s will be monitored for AEs and SAEs.
Follow-ups visits will be conducted on Day 7 and Day 30. Data from each visit will be collected and recorded in CRFs, and analyzed accordingly. Safety and performance endpoints will be evaluated using descriptive statistics. The investigator will assess and categorize adverse events based on their severity and relationship to the device.
Description of the investigational device-
Diagnostic catheters are specialized diagnostic intravascular catheters used for the coronary diagnostic angiography performed as part of diagnostic cardiac catheterization. The basic design of diagnostic catheter comprises of a catheter tube having a proximal end and a distal end. A Nylon lumen extends from the proximal end of the diagnostic catheter to the distal end of the catheter and is configured to serve as a conduit for contrast media delivery, catheter flushing and pressure measurement during cardiac catheterization procedure. The lumen of the catheter is also designed to house a guidewire. The diagnostic catheter are designed to allow access into the arterial vasculature from access sites such as femoral, radial, and brachial arteries. Diagnostic catheter manufactured with different material (Polycarbonate, Pebax, Polyurethane, Polyamide, Stainless Steel, Nylon.
Primary Objective:
To assess the safety of the diagnostic catheter in angiography procedures.
Secondary Objective:
To evaluate the performance of the diagnostic catheter in successfully facilitating contrast injection and imaging.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Male or female subjects aged 18 years and above.
- •2.Subjects undergoing angiography requiring a diagnostic catheter for contrast injection.
- •3.Subjects with suitable vascular anatomy for catheter placement.
- •4.Ability to provide written informed consent.
Exclusion Criteria
- •1.Subjects with severe vascular calcification or tortuosity that may impede catheter advancement.
- •2.Presence of active infection at the catheter insertion site.
- •3.Subjects with coagulopathy or on anticoagulant therapy, increasing the risk of bleeding.
- •4.History of vascular dissection or aneurysm at the planned access site.
- •5.Pregnant or lactating women.
Outcomes
Primary Outcomes
The primary outcome of the study is the performance of the diagnostic catheter during angiographic procedures. This includes catheter should facilitate smooth and successful navigation through the blood vessels, ensuring stable positioning for angiographic imaging Additionally, it should enable effective contrast injection, providing clear imaging for accurate diagnosis of vascular lesions and determining the need for PTCA.
Time Frame: In this clinical study, follow-ups will be conducted on the 7th day and 30th day. Data collected at each follow-up will be assessed, recorded, and analyzed to evaluate safety, performance, and any adverse events.
Secondary Outcomes
- The secondary outcome of the study is the safety, the catheter is expected to have a low incidence of AEs and SAEs, including vessel perforation, thromboembolism, vasospasm, device-related infections, and complications at the insertion site. It should not cause significant trauma to vascular structures during insertion, navigation, or removal.(In this clinical study, follow-ups will be conducted on the 7th day and 30th day. Data collected at each follow-up will be assessed, recorded, and analyzed to evaluate safety, performance, and any adverse events.)
Investigators
Dr N Rajasekar
Sudha Hospitals