CLINICAL EVALUATION OF THE INDIGENOUSLY MANUFACTURED REJUVENATE® BARE METAL STENT SYSTEM IN PAKISTANI PATIENTS WITH CORONARY ARTERY DISEASE

Abstract

Objectives: The aim of this pilot study was the first-in-man evaluation of the safety, feasibility, deliverability, and efficiency of the newly developed REJUVENATE® bare metal stent system in coronary artery disease.

Methodology: Current study was a pilot non-randomized, multi-centric and prospective study which was intended to study the safety of the REJUVENATE® bare metal stent in Pakistani population over 10 months. Study endpoints included target vessel related myocardial infarction, stent thrombosis, in-stent restenosis, stroke and death. The diameter of the target lesions selected was between 3-4mm with length no more than 22mm. Only one BMS was implanted per patient. These patients had well defined regular clinical follow-ups and CT scan coronary angiography at the end of 10 months.

Results: 20 patients suffering from coronary artery disease (CAD) including15 male subjects and 5 female subjects were enrolled in this study and were treated with REJUVENATE® BMS. 65% patients were hypertensive, 25% diabetics and 25% were active smokers. Out of the 20 stents implanted, 14 stents were implanted in the right coronary artery and 6 were implanted in the left circumflex artery. During this 10-month study period there was 10.65% of cases in which late lumen loss (lumen stenosis <70%) was observed, however no cases of in stent restenosis and stent thrombosis were observed. There was no target vessel related myocardial infarction or stroke as well. One patient died of pneumonia during the follow up period.

Conclusion: The current study demonstrated the deliverability and clinical safety of REJUVENATE® bare metal stent over a period of 10 months.