NCT03616132

A First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

A Prospective, Non-randomized, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System（IBS）. The main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of IBS. To provide the basis for subsequent large-scale, multi-center, randomized controlled clinical trials of IBS.

Detailed description

* A prospective, non-randomized trial * Study population: 15 patients * Clinical follow up will be required at postoperative, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years; * All the subjects perform the angiography, Intra-vascular ultrasound (IVUS) and Optical coherence tomography (OCT) at 1 year and 3 years. * The primary study endpoint is target lesion failure (TLF) at 1 month post procedure; and imaging findings as the secondary study endpoint. To evaluate the feasibility, safety and performance of IBS.

Conditions

• Single Coronary Vessel Disease

Interventions

Type	Name	Description
DEVICE	Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System	Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)

Timeline

• Start date: 2018-03-28
• Primary completion: 2019-03-30
• Completion: 2023-03-30
• First posted: 2018-08-06
• Last updated: 2018-08-06

Locations

2 sites across 1 country: Malaysia