The Bovine Pericardial Tissue Patch is intended for use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency reconstruction and repair, and reinforcing the suture line during general surgical procedures.

A PMCF study to evaluate the safety and efficacy of the Bovine Pericardial Tissue Patch in Vascular Surgeries - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079365

Enrollment

Registered

2025-01-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: I73- Other peripheral vascular diseases

Interventions

Intervention1: Bovine Pericardial Tissue Patch: Intended for use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency repair, and reinforcing the suture line

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 years and older undergoing vascular surgery requiring a patch graft.

Exclusion criteria

Exclusion criteria: 1.Patients with known allergies to bovine products or pre-existing conditions contraindicating the use of bovine pericardial patches. 2.Patients with uncontrolled infections 3.Pregnant patients.

Design outcomes

Primary

Measure	Time frame
1.Safety: Incidence of adverse events related to the use of bovine pericardial patch, including infections, thrombosis, and allergic reactions. 2.Efficacy: Patency rates of vascular grafts assessed through imaging studies - Doppler ultrasound at specified follow-up intervals. 3.Patch handling and characteristicsTimepoint: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months,6 months and 1 year.	—

Measure

Time frame

1.Safety: Incidence of adverse events related to the use of bovine pericardial patch, including infections, thrombosis, and allergic reactions. 2.Efficacy: Patency rates of vascular grafts assessed through imaging studies - Doppler ultrasound at specified follow-up intervals. 3.Patch handling and characteristicsTimepoint: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months,6 months and 1 year.

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Secondary

Measure	Time frame
1.Patients will be examined post-surgery by evaluating the occurrence of wound infection, hematoma, partial thrombosis, thrombotic occlusion, pseudoaneurysm, stroke, myocardial infarction, carotid artery thrombosis, paralysis, restenosis 2.Mortality rate.Timepoint: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6 months and 1 year.	—

Measure

Time frame

1.Patients will be examined post-surgery by evaluating the occurrence of wound infection, hematoma, partial thrombosis, thrombotic occlusion, pseudoaneurysm, stroke, myocardial infarction, carotid artery thrombosis, paralysis, restenosis 2.Mortality rate.Timepoint: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6 months and 1 year.

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Countries

India

Contacts

Public ContactDr Robbie K George

Mazumdar Shaw Medical Center- a unit of Narayana Health

robbie.george.dr@narayanahealth.org9538896751

Outcome results

None listed

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