The purpose of this clinical investigation is to assess the safety and performance of the diagnostic catheter when used in angiographic procedures. This study aims to generate clinical evidence supporting the safe and effective use of the device in real-world settings.

A prospective study to evaluate the safety and performance of a Angiographic catheter Diagnostic catheter in Angiographic procedures - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093386

Enrollment

Registered

2025-08-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I30-I52- Other forms of heart disease

Interventions

Intervention1: Diagnostic Catheter: Diagnostic catheters are specialized diagnostic intravascular catheters used for the coronary diagnostic angiography performed as part of diagnostic cardiac cathete

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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.	—

Measure

Time frame

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.Timepoint: 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.

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Secondary

Measure	Time frame
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.Timepoint: 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.	—

Measure

Time frame

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.Timepoint: 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.

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Countries

India

Contacts

Public ContactDr N Rajasekar

Sudha Hospitals

sekarjumbo@gmail.com919894634040

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026