Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fudan University | OTHER |
Not provided
Not provided
Not provided
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
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) .
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cordimax | Experimental | Rapamycin Eluting Coronary Stent |
|
| XIENCE V | Active Comparator | Everolimus Eluting Coronary Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cordimax | Device | One rapamycin eluting stent for treating the adapted coronary patients |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure(TLF) | including Cardiac death, target vessel myocardial infarction, and clinical symptom driven target vessel revascularization | at 1st year |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombotic events incidence | According to ARC definition it includes deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d | at30 60 90 days and 1st 2st 3st 4st 5st year |
| Major adverse cardiovascular events (MACE) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Beijing | Beijing Municipality | 100032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| XIENCE V |
| Device |
One everolimus eluting stent for treating the adapted coronary patients |
|
Events include cardiac death, myocardial infarction of target vessel and target lesion revascularization (TLR) by clinical-driven |
| at30 60 90 days and 1st 2st 3st 4st 5st year |
| The Success Rate of Stent Placement | The stent can arrive and through the target lesion area, and can be expanded finally. | in the operation |
| Operation Success Rate | After stent implantation, stent diameter stenosis < 30% (visual), TIMI flow class 3, and hospitalization MACE events did not happen. | 0 to 24 hours after intervention |
| Cost of the hospitalization | The total expenses in the process of operation | 0 to 24hours after discharge |
| Length of stay | The total time consumption in the process of operation | 0 to 24 hours after discharge |
| D014652 |
| Vascular Diseases |