Post-market study of Pipit-SC Balloon Dilatation Catheter

Post-market Evaluation of Safety and Performance of PIPIT-SC PTCA Catheter in Patients with Stenotic Coronary Arteries During Percutaneous Coronary Intervention - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/05/086573

Enrollment

Registered

2025-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: I209- Angina pectoris, unspecified

Interventions

Intervention1: Pipit-SC Balloon Dilatation Catheter: PIPIT-SC is a percutaneous transluminal coronary angioplasty Balloon Dilatation Catheter. It is designed to allow easy exchange of the catheter usi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient must be at least 18 years of age 2. Patient or a legally authorized representative must provide written informed consent prior to any study related procedure 3. Patient must agree not to participate in any other clinical study during hospitalization for the index procedure 4. Target lesion(s) can be treated with PIPIT-SC PTCA Balloon Dilatation Catheter as per the current IFU

Exclusion criteria

Exclusion criteria: Patient not meeting any of the above inclusion criteria

Design outcomes

Primary

Measure	Time frame
1. Device Success 2. Procedural successTimepoint: Baseline (From the start to end of the interventional procedure)	—

Secondary

Measure	Time frame
1. Individual procedural parameters Coronary perforation Coronary dissection Coronary thrombosis Clinically significant arrhythmias (requiring intervention)Timepoint: Up to end of PTCA procedure;2. Safety endpoints All-cause mortality Any myocardial infarction (MI) Any revascularizationTimepoint: Up to hospital discharge	—

Countries

India

Contacts

Public ContactDr Atul D Abhyankar

Shree B. D. Mehta Mahavir Heart Institute

atulda.abhyankar@gmail.com9824145738

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026