NCT02448524

Clinical Trial on the Efficacy and Safety of Sirolimus-Eluting Stent (MiStent® System)

A Prospective, Single-blinded, Multi-center, Randomized, Controlled, Registered Clinical Trial on the Efficacy and Safety of Sirolimus-eluting Stent (MiStent® System) in the Treatment of Patients With Coronary Heart Disease

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 428 (actual)
• Sponsor: Micell Technologies · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

* To evaluate the safety and efficacy of MiStent drug (sirolimus)-eluting stent system in the treatment of coronary heart disease (CHD) in patients with primary in situ CHD (de novo); * To evaluate operating performance of the MiStent drug (sirolimus)-eluting coronary stent system.

Detailed description

* The study will enroll a total of 428 cases of primary in situ coronary artery disease patients (all patients enrolled with a maximum of two target lesions in different blood vessels and maximum of 2 stents per lesion. If more stents are needed for implantation, stents with the same brand are required, and mixing brands is not allowed for each patient except for salvage with implantation of other brand of stents.) * Lesions with reference diameter of 2.5mm-3.5mm (by visual measurement) and with length ≤40mm (by visual measurement) will be selected, subjects meeting the inclusion and exclusion criteria and who agree to participate will be enrolled. * Prospective, single-blinded, multi-center, randomized, controlled clinical trial; * Patients with in situ primary CHD; * Clinical sites: up to 18; patients will be enrolled in a 1:1 ratio (i.e., 214 cases enrolled into each group, the MiStent stent group and TIVOLI stent group); * Clinical follow-up time points: 1 month, 6 months, 9 months, 12 months and yearly at 2-5 years post index procedure; * Angiographic follow-up at 9 months post index procedure; in-stent late lumen loss measured by quantitative coronary angiography (QCA) will be used as the primary efficacy endpoint for product evaluation; * In this trial, the collection, collation, statistical analysis and adjudication of all relevant clinical and angiographic data will be conducted by an independent coronary angiography core laboratory (CCRF Medical Technology Co., Ltd.), data management and statistical center, clinical events committee and clinical audit agency. All patients will be followed up for 5 years (by telephone or outpatient form), and the incidence of adverse events will be recorded to allow a more accurate and reliable evaluation of the long-term safety of the MiStentTM drug (sirolimus) eluting coronary stent system.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	MiStent	Primary in situ coronary artery disease patients (all patients enrolled with a maximum of two target lesions in different blood vessels and maximum of 2 stents per lesion. Lesions with reference diameter of 2.5mm-3.5mm (by visual measurement) and with length ≤40mm (by visual measurement).
DEVICE	TIVOLI	Primary in situ coronary artery disease patients (all patients enrolled with a maximum of two target lesions in different blood vessels and maximum of 2 stents per lesion. Lesions with reference diameter of 2.5mm-3.5mm (by visual measurement) and with length ≤40mm (by visual measurement).

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-11-30
• Completion: 2022-11-01
• First posted: 2015-05-19
• Last updated: 2020-09-04

Locations

16 sites across 1 country: China