The purpose of this clinical study is to evaluate the safety, performance, and procedural efficiency of a PTCA Balloon Dilatation Catheter, including both semi-compliant and non-compliant balloon types, in subjects undergoing coronary angioplasty.

A Prospective Clinical Study to Evaluate the Safety and Performance of PTCA Balloon Dilatation Catheters in Patients Undergoing Coronary Angioplasty. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093146

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: PTCA Balloon Dilatation Catheter: PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the pu

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female subjects aged 18 years and above 2.Subjects diagnosed with coronary artery disease requiring percutaneous coronary intervention (PCI). 3.No prior stenting at the target lesion within the last 6 months. 4.Subjects with suitable vascular anatomy for catheter placement. 5.Ability to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Known allergy to contrast media or balloon catheter materials. 2.Subjects with an unprotected left main coronary artery. 3.Subjects with coronary artery spasm in the absence of a significant stenosis. 4.Bleeding diathesis or contraindication to anticoagulation. 5.Pregnant or lactating women or women of childbearing potential not using adequate contraception.

Design outcomes

Primary

Measure	Time frame
evaluation on safety of the PTCA Balloon Dilatation Catheter in achieving successful balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis.Timepoint: Follow-ups will be conducted on Day 7 and Day 30, data collected at each follow-up will be assessed, recorded, and analysed to evaluate safety and performance.	—

Secondary

Measure	Time frame
To assess the device performance characteristics including balloon deliverability, trackability, crossing profile, inflation/deflation times, balloon integrity, & compatibility with guidewires & stents during the procedure.Timepoint: Follow-ups will be conducted on Day 7 & Day 30, data collected at each follow-up will be assessed, recorded, & analysed to evaluate safety & performance.	—

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