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Study aims to evaluate the safety of the MANTA Vascular Closure Device in patients in India.

Prospective clinical study evaluating contemporary MANTA safety outcomes in India (MANTA Safety Study in India)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/084357
Enrollment
59
Registered
2025-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis

Interventions

Intervention1: Nil: Non-interventional Study Control Intervention1: NIL: Non-interventional study

Sponsors

Teleflex Medical India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Candidate meets criteria for on-label use of MANTA VCD as specified in MANTA VCD Instructions for Use (IFU), as per judgement of the investigator. 2.Age 21 years & above.

Exclusion criteria

Exclusion criteria: Before the procedure- 1.Unable or unwilling to give informed consent or unwilling to complete follow-up assessments. 2.Severe calcification of the access vessel. 3.Severe peripheral artery disease. 4.Marked tortuosity of the femoral or iliac artery. 5.Patients who cannot be anti-coagulated for the procedure 6.Marked obesity or cachexia (BMI above 40 or below 20). During the TAVR/EVAR/TEVAR procedure- 7.Puncture in the origin of the profundal femoral artery, above the inguinal ligament, or above the most inferior border of the epigastric artery (IEA). 8.Sheath insertion in the vessel other than the femoral artery. 9.Blood Pressure above 180 mmHg.

Design outcomes

Primary

MeasureTime frame
VCD Large Bore Access-site Related VARC-3 Major & Minor Vascular complications through discharge following TAVR/EVAR/TEVAR procedure (adapted from VARC-3 Criteria 1).Timepoint: 1 Month—

Secondary

MeasureTime frame
Additional interventions required at large bore access site to address bleeding or other large bore access site complications (e.g., bare, or covered stent, or surgical repair) through discharge following TAVR/EVAR/TEVAR procedure, reported by Investigators. Timepoint: 1 Month;VCD Large Bore Access-site Related VARC- 3 Major & Minor Vascular complications within 30 days of TAVR/EVAR/TEVAR procedure (adapted from VARC-3 Criteria1); reported by Investigators.Timepoint: 1 Month—

Countries

India

Contacts

Public ContactDr Prashanth S Prakash

Teleflex Medical India Pvt Limited

prashanth.srirangapattanaprakash@teleflex.com9964566700

Outcome results

None listed

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