To check the Safety and Effectiveness of the Balloon Dilatation Catheter in Patients Undergoing Coronary Angioplasty

A prospective, single-arm, open-label, multi-center, observational, real-world, post-market clinical follow-up study to evaluate the safety and performance of Mural SC Semi-Compliant Rx PTCA Balloon Dilatation Catheter. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/12/099451

Enrollment

Registered

2025-12-19

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 above 18 years, irrespective of gender. 2. Participants must be willing and able to provide written Informed Consent by signing and dating the IRB or ECapproved Informed Consent Form. 3. The participants should be able to comply with protocol requirements and assessments. 4. Participants with cardiovascular stenosis who are undergoing an endovascular procedure requiring vessel dilatation and treated with Mural SC Semi-Compliant Rx PTCA Balloon Dilatation Catheter. 5. Participants with percutaneous transluminal coronary angioplasty. 6. Participants undergoing treatment for obstructive lesions in a native coronary artery or bypass grafts, or need postdilatation of a coronary stent. 7. Target lesion amenable to treatment with the Mural SC Semi-Compliant Rx PTCA Balloon Dilatation Catheter .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
1. Major adverse cardiac events (MACE) 2. Device SuccessTimepoint: 1. Post operative , 7 days , 1 month, 3 months, 6 months, 12 months 2. Intra Operative	—

Secondary

Measure	Time frame
1. Procedural Success 2. Target Vessel Revascularization 3. Rate of Balloon Bursting 4. Change in Late Lumen Loss 5. Ease of Use 6. Product Performance 7. Adverse and Serious adverse events Timepoint: 1.Post operative 2.Post operative , 7 days , 1 month, 3 months , 6 months , 12 months 3. Intra Operative 4. Pre operative , Post Operative , 6 months 5. Intra Operative 6. Intra Operative 7. Post Operative , Discharge , 7 days , 1 month, 3 months,6 months , 1 year	—

Measure

Time frame

1. Procedural Success 2. Target Vessel Revascularization 3. Rate of Balloon Bursting 4. Change in Late Lumen Loss 5. Ease of Use 6. Product Performance 7. Adverse and Serious adverse events Timepoint: 1.Post operative 2.Post operative , 7 days , 1 month, 3 months , 6 months , 12 months 3. Intra Operative 4. Pre operative , Post Operative , 6 months 5. Intra Operative 6. Intra Operative 7. Post Operative , Discharge , 7 days , 1 month, 3 months,6 months , 1 year

—

Countries

India

Contacts

Public ContactDr KiranKumar Shetty

Meril Life Sciences Pvt Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

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