NCT03185221

Cordimax China Post Market Surveillance

Comparing the Safety and Efficacy of Cordimax and Xience V Drug-eluting Stents, for the Treatment of Coronary Heart Disease (CHD) in the Clinical Research of Real World

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,660 (actual)
• Sponsor: Shandong Branden Med.Device Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the real world. Study group Experimental group: Cordimax® Rapamycin Eluting Coronary Stent System Control group: XIENCE V® Everolimus Eluting Coronary Stent System

Detailed description

The purpose of the post market clinical trial is to evaluate the safety and efficacy of the Cordimax Rapamycin Eluting Coronary Stent System (RECS). The Cordimax will be compared to an active control group represented by the FDA approved commercially available Abbott Vascular XIENCE V® EECS Everolimus Eluting Coronary Stent System. The post market clinical trial consists of a randomized clinical trial (RCT) in China which will enroll approximately 3660 subjects (2:1 randomization Cordimax® RECS : XIENCE V® EECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes \>= 2.5 mm and \<= 4 mm. All subjects in the RCT will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the XIENCE V® arm of US RCT. All subjects will have clinical follow-up at 30, 60, 90days, and 1, 2, 3, 4, and 5 years so as to collect the needed data for the subsequent analysis.(Data collecting at 1st year will be conducted in the clinic in order to get the 12 lead ecg result once after out of the hospital) .

Conditions

• Coronary Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Cordimax	One rapamycin eluting stent for treating the adapted coronary patients
DEVICE	XIENCE V	One everolimus eluting stent for treating the adapted coronary patients

Timeline

• Start date: 2013-06-20
• Primary completion: 2019-06-20
• Completion: 2020-06-20
• First posted: 2017-06-14
• Last updated: 2017-06-14

Locations

1 site across 1 country: China