China-based Lifetech Scientific Corporation (HKG: 1302) announced that all patients have been enrolled in a prospective, multi-center, randomized controlled Phase II clinical study for its IBS absorbable drug-eluting coronary stent system in China.
Study Design and Results
The study, expected to involve upwards of 40 clinical centers across the country, is designed to assess the safety and efficacy of the product in coronary heart disease. A total of 518 subjects were enrolled and grouped at a random 1:1 ratio. The results showed that the success rate was 100%, and there was no instrument-related serious adverse event (SAE) at present.
IBS Coronary Stent Features
The matrix of the IBS coronary stent is made of a high-strength, high-plasticity, and high-purity nitrided iron tube. The total wall thickness of the stent rod is only 70-80 μm, and the supporting force is strong. The product begins to degrade 3-6 months after implantation, and enters the end of degradation in about 2 years, eventually being absorbed by human tissues so as to effectively avoid a series of long-term prognosis problems that may be caused by the implantation of permanent metal stents.
Previous Study Results and Future Plans
Previously, the two-year follow-up results of an FIM clinical study for the IBS coronary stent preliminarily demonstrated that it had good mid-term safety and efficacy in simple primary coronary disease. Angiography (QCA) and intravascular optical coherence tomography (OCT) measurements showed that the mean lumen area of the target vessel continued to expand six months after the implantation of the IBS coronary stent. A prospective, multi-center, single-group target value Phase III clinical study for the product is on the horizon.-Fineline Info & Tech
