Development of artificial blood vessel

Controlled Clinical Trial of Sitra-Chitra vascular graft prosthesis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/10/005140

Enrollment

Registered

2014-10-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients suffering from abdominal aortic aneurysms and thoraic aortic coarctation who are at good risk with normal sub-system functions

Interventions

Intervention1: Polyester vascular prosthesis: Woven seamless graft made of polyethylene terephthalate (PET) Control Intervention1: Artifical graft commercially available: Polyester (polyethylene terep

Eligibility

Inclusion criteria

Inclusion criteria: Trial included test graft (Sitra-Chitra prosthesis) implantation in 10 patients who required surgical treatment for abdominal aortic aneurysm and thoracic aortic co-arctation. Also 10 control graft implantations in 10 such patients

Exclusion criteria

Exclusion criteria: 1. Age 20 years and 80years 2. Patient with significant cardio-respiratory and renal morbidity

Design outcomes

Primary

Measure	Time frame
Early outcomes: 1. Mortality and major morbidity Late outcomes: Long-term graft functionTimepoint: 5 years	—

Secondary

Measure	Time frame
Long-term graft functionTimepoint: longer than 5 years (we already have followed up for 10 years by now)	—

Countries

India

Contacts

Public ContactMadathipat Unnikrishnan

Sree Chitra Tirunal Institute for Medical Sciences and Technology

unni@sctimst.ac.in9847145660

Outcome results

None listed

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