The purpose of this clinical study is to evaluate the efficacy and safety of PTFE guidewires when used in angioplasty and angiography procedures.

A Prospective Clinical Investigation to Evaluate the Safety and Performance of a PTFE Guidewire in Angioplasty and Angiography - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093147

Enrollment

Registered

2025-08-18

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: PTFE Guidewire: PTFE Guidewire for percutaneous entry and guidance of catheters, the Diagnostic Guidewire complements our diagnostic catheter and catheter sheath introducer lines. Perfo

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female subjects aged 18 years and above. 2.Subjects undergoing angiography or angiography or both requiring PTFE guide wire to support for the catheter, facilitating balloon inflation and stent placement. 3.Subjects with suitable vascular anatomy for PTFE guidewire navigation. 4.Ability to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Subjects with severe vascular calcification or tortuosity that may prevent PTFE guidewire advancement. 2.Presence of active infection at the device 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. 6.Subjects requiring guide wire use in the coronary arteries or neurovasculature.

Design outcomes

Primary

Measure	Time frame
To assess the safety of the PTFE guidewire when used in angioplasty and angiography procedures.which focuses on the guidewire?s ability to minimize vessel trauma, enhance navigation particularly in complex anatomical regions and improve overall procedural outcomes.Timepoint: Follow-ups will be conducted on Days 7 and 30. Data collected at each follow-up will be assessed, recorded, and analyzed to evaluate safety and performance.	—

Measure

Time frame

To assess the safety of the PTFE guidewire when used in angioplasty and angiography procedures.which focuses on the guidewire?s ability to minimize vessel trauma, enhance navigation particularly in complex anatomical regions and improve overall procedural outcomes.Timepoint: Follow-ups will be conducted on Days 7 and 30. Data collected at each follow-up will be assessed, recorded, and analyzed to evaluate safety and performance.

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Secondary

Measure	Time frame
To evaluate the performance of the PTFE guidewire in effectively supporting the catheter & assisting with image.The study claims that PTFE guidewires are expected to demonstrate a low incidence of adverse events (AEs) & serious adverse events (SAEs). Additionally, their use is associated with improved procedural efficiency, enhanced device navigation, reduced risk of complications, better patient outcomes, & quicker recovery times.Timepoint: Follow-ups will be conducted on Days 7 & 30. Data collected at each follow-up will be assessed, recorded, & analyzed to evaluate safety & performance.	—

Measure

Time frame

To evaluate the performance of the PTFE guidewire in effectively supporting the catheter & assisting with image.The study claims that PTFE guidewires are expected to demonstrate a low incidence of adverse events (AEs) & serious adverse events (SAEs). Additionally, their use is associated with improved procedural efficiency, enhanced device navigation, reduced risk of complications, better patient outcomes, & quicker recovery times.Timepoint: Follow-ups will be conducted on Days 7 & 30. Data collected at each follow-up will be assessed, recorded, & analyzed to evaluate safety & performance.

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Countries

India

Contacts

Public ContactDr N Rajasekar

Sudha Hospitals

sekarjumbo@gmail.com09894634040

Outcome results

None listed

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