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NAUTICA Intracoronary Shunt(The NAUTICA Intracoronary Shunt is a radio-opaque, one-piece device consisting of a flexible hollow shaft having bulb-shaped distal tips.)

A retrospective, singlearm, multi-centre, observational, real-world, clinical followup study to evaluate the safety and performance of the NAUTICA Intracoronary Shunt. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/084195
Enrollment
172
Registered
2025-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: I798- Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Meril Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who underwent vessel anastomosis procedure by temporarily throttling the blood flow towards a distal bypass route from anastomotic site in the vessel and treated with NAUTICA™ Intracoronary Shunt.

Exclusion criteria

Exclusion criteria: 1. Patients who have not been treated by using the NAUTICA™ Intracoronary Shunt are excluded from the study.

Design outcomes

Primary

MeasureTime frame
1. Major adverse cardiac and cerebrovascular events (MACCE) 2.Anastomosis time/duration of anastomosisTimepoint: 1. Time Frame: Intra-operative and post-operative 2. Time Frame: Intra-operative—

Secondary

MeasureTime frame
1.Hyperdynamic shock 2.Recurrence of angina 3.Incidence rate of myocardial infarction 4.Device-related complications 5.Mechanical ventilation time 6.Length of hospital stayTimepoint: 1.Time Frame: Post-operative 2.Time Frame: Postoperative 3.Time Frame: Post-operative 4.Time Frame: Intraoperative and post-operative 5.Time Frame: Postoperative 6.Time Frame: Admission to discharge—

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: Feb 4, 2026