title: The making of indigenous vascular prosthesis.
abstract: OBJECTIVE
  Vascular illnesses are on the rise in India, due to increase in lifestyle diseases and demographic transition, requiring intervention to save life, organ or limbs using vascular prosthesis. The aim of this study was to develop indigenous large diameter vascular graft for treatment of patients with vascular pathologies.
  
  
  METHODS
  The South India Textile Research Association, at Coimbatore, Tamil Nadu, India, developed seamless woven polyester (Polyethylene terephthalate) graft at its research wing. Further characterization and testing followed by clinical trials were conducted at Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India. Fifteen in vivo experiments were carried out in 1992-1994 in pigs as animal model. Controlled (phase I) clinical trial in ten patients was performed along with control graft. Thereafter, phase II trial involved 22 patients who underwent multi-centre clinical trial in four centres across India.
  
  
  RESULTS
  Laboratory testing showed that polyester graft was non-toxic, non-leeching and non-haemolytic with preserved long-term quality, further confirming in pigs by implanting in thoracic aorta, comparable to control Dacron grafts. Perigraft incorporation and smooth neointima formation which are prime features of excellent healing characteristics, were noted at explantation at planned intervals. Subsequently in the phase I and II clinical trials, all patients had excellent recovery without mortality or device-related adverse events. Patients receiving the test graft were followed up for 10 and 5 years, respectively. Serial clinical, duplex scans and CT angiograms performed periodically confirmed excellent graft performance.
  
  
  CONCLUSIONS
  Indigenously developed Chitra vascular graft was comparable to commercially available Dacron graft, ready for clinical use at affordable cost to patients as against costly imported grafts.
authors.affiliation: Division of Vascular Surgery, Department of Cardiovascular & Thoracic Surgery, Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Thiruvananthapuram, India.
authors.forename: Madathipat
authors.initials: M
authors.lastname: Unnikrishnan
authors.affiliation: Division of Vascular Surgery, Department of Cardiovascular & Thoracic Surgery, Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Thiruvananthapuram, India.
authors.forename: Sidharth
authors.initials: S
authors.lastname: Viswanathan
authors.affiliation: Weaving & Knitting Division, South India Textile Research Association, Coimbatore, India.
authors.forename: K
authors.initials: K
authors.lastname: Balasubramaniam
authors.affiliation: Division of Artificial Internal Organs, SCTIMST, Thiruvananthapuram, India.
authors.forename: C V
authors.initials: CV
authors.lastname: Muraleedharan
authors.affiliation: Division of In-Vivo Models and Testing, SCTIMST, Thiruvananthapuram, India.
authors.forename: Arthur Vijayan
authors.initials: AV
authors.lastname: Lal
authors.affiliation: Division of Toxicology, SCTIMST, Thiruvananthapuram, India.
authors.forename: P V
authors.initials: PV
authors.lastname: Mohanan
authors.affiliation: Division of Experimental Pathology, SCTIMST, Thiruvananthapuram, India.
authors.forename: Meera
authors.initials: M
authors.lastname: Mohanty
authors.affiliation: Department of Imaging Sciences & Interventional Radiology, SCTIMST, Thiruvananthapuram, India.
authors.forename: Tirur Raman
authors.initials: TR
authors.lastname: Kapilamoorthy
mesh_terms: D000818:Animals; D001011:Aorta / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D001014:Aortic Aneurysm / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D001807:Blood Vessel Prosthesis / Q000009:adverse effects*; D004195:Disease Models, Animal; D005500:Follow-Up Studies; D056973:Four-Dimensional Computed Tomography; D006801:Humans; D013552:Swine; D014652:Vascular Diseases / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D058017:Vascular Grafting / Q000009:adverse effects*