To assess the safety and performance of Mural Non-Complaint Balloon

A Prospective, Multi Center, Single Arm, Open Label, Observational, Real World, Post Market Clinical Follow up Study to Evaluate the Safety & Performance of Mural NC Non Compliance Rx PTCA Balloon Dilatation Catheter - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/03/105735

Enrollment

106

Registered

2026-03-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: I748- Embolism and thrombosis of other arteries

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants aged 18 and above, irrespective of gender. 2. Participants with cardiovascular stenosis who are undergoing endovascular procedure requiring vessel dilatation and treated with Mural NC Non-compliant Rx PTCA Balloon Dilatation Catheter. 3. Participants with percutaneous transluminal coronary angioplasty. 4. Participants with to treat obstructive lesions of a native coronary artery or aortocoronary bypass, or need post-dilatation of a coronary stent. 5. Mural NC Non-compliant Rx PTCA Balloon Dilatation Catheter used in the primary lesion treated during the procedure by the decision physician. 6. Participant who has been provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Participants with unprotected left main coronary artery lesions. 2. Participants having coronary artery spasm in the absence of a significant stenosis. 3. Pregnant or lactating women. 4. Participants with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, or materials such as pebax, nylon, stainless steel, polytetrafluoroethylene, sodium hyaluronate, or any contrast media. 5. Participating in another medical device or pharmaceutical clinical trial. 6. The participant who is unwilling or unable to sign the Informed Consent Document.

Design outcomes

Primary

Measure	Time frame
1. Procedure Success 2. Major Adverse Cardiac events 3. Angiographic SuccessTimepoint: 1. Intra-operative 2. Through discharge, 7 days 2 days, 30 days 7 days, 3 months 15 days, 6 months 30 days, 1 year 30 days. 3.Intraoperative	—

Secondary

Measure	Time frame
1. Freedom from Balloon Rupture 2. Freedom from Coronary Perforation 3. Procedure Time 4. Stent Thrombosis Changes 5. Lesion cross and inflation - deflation cycles 6. Adverse Events 7. Target Lesion Failure 8. Short Form 36 9. Ease of UseTimepoint: 1. Inra Operative 2. Intra Operative 3. Intra Operative 4. Intra Operative 5. Intra - Operative 6. Through discharge, 7 days, 30 days, 3 months, 6 months, 1 year 7.6 Months, 1 year 8. Pre opeartive , Discharge , 7 days , 30 days , 3 months, 6 months , 1 year 9. Intra Operative	—

Measure

Time frame

1. Freedom from Balloon Rupture 2. Freedom from Coronary Perforation 3. Procedure Time 4. Stent Thrombosis Changes 5. Lesion cross and inflation - deflation cycles 6. Adverse Events 7. Target Lesion Failure 8. Short Form 36 9. Ease of UseTimepoint: 1. Inra Operative 2. Intra Operative 3. Intra Operative 4. Intra Operative 5. Intra - Operative 6. Through discharge, 7 days, 30 days, 3 months, 6 months, 1 year 7.6 Months, 1 year 8. Pre opeartive , Discharge , 7 days , 30 days , 3 months, 6 months , 1 year 9. Intra Operative

—

Countries

India

Contacts

Public ContactDr KiranKumar Shetty

Meril Life Sciences Pvt. Ltd

kirankumar.shetty@merillife.com09743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026