A Postmarket Clinical Trial for EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT
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|ClinicalTrials.gov Identifier: NCT03716011|
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
- Prospective, randomized, multicenter clinical study
- This is a post-marketing clinical study to evaluate whether it will affect the safety event when it is used in different treatment ways. Adopting non - inferiority design, 2700 cases were enrolled.
- EDC system (eCRF electronic data collection system)
- Follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation;
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: EXCROSSAL||Not Applicable|
- Subjects are eligible for coronary intervention
- The lesion needs to be pre-expanded or special circumstances should be carefully considered according to the clinical manifestations
- The selection of target vessel is based on the criteria of a diameter between 2.25mm and 4.0mm
- If a stent needs to be placed at the target vessel, it is recommended that there be at least 2mm overlap between the stents; if the stent expansion is not sufficient, post-dilatation treatment is required.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2700 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||the EXCROSSAL stent in CAD patients with 3-month DAPT or 12-month DAPT|
|Masking:||None (Open Label)|
|Official Title:||A Large, Prospective, Randomized, Multicenter Clinical Study Evaluating the Safety and Efficacy of the Post-marketing Drug-eluting Stent System (Rapamycin) - the EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT|
|Estimated Study Start Date :||December 20, 2018|
|Estimated Primary Completion Date :||December 20, 2021|
|Estimated Study Completion Date :||December 20, 2025|
DAPT 3M or DAPT 12M
After stent implantation in DAPT 3M or DAPT 12M
a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent
- Target lesion failure at 12-Month [ Time Frame: 12-month ]The target lesion failure (TLF) rate at 12 months after operation involves cardiac death, target-vessel myocardial infarction, and clinical-symptom driven target vessel revascularization.
- MACE rate [ Time Frame: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month. ]
Incidence of major adverse cardiac events (MACE) at different follow-up points of 1-month,3-month,6-month,12-month,24-month,36-month,48-month,60-montjh.
2. Stent implantation success rate (covering the device success, the lesion success and the clinical success); 3. Target lesion failure (TLF) at 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation; 4. Subject-related cardio-clinical composite end points at the follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation, covering all-cause mortality, all myocardial infarctions and any revascularization; 5. The incidence of ARC-defined stent thrombosis events (defined, probable and non-excludable stent thrombosis in early, late, and delayed stages);
- Device success rates , lesion success rates , clinical success rates [ Time Frame: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month. ]
The success of the instrument refers to the degree of stenosis in the final bracket after the instrument was implanted. Lt; 30 %(visual), TIMI level 3 blood flow, and no residual stenosis and thrombus.
The success of the lesion refers to the degree of ultimate diameter stenosis of the target lesion after the application of any interventional treatment. 50 %(visual), TIMI level 3 blood flow, and no residual stenosis and thrombus.
The success of surgery refers to the absence of major cardiac adverse events caused by ischemia during the patient's hospitalization(up to 7 days after surgery) based on the success of the lesion.
- Definite and probable stent thrombosis [ Time Frame: 1-month,3-month, 12-month, 24-month, 36-month, 48-month and 60-month. ]According to ARC definition
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716011
|Contact: Lei M Ge, Ph.D||+86 10 50981788 ext firstname.lastname@example.org|
|Contact: Junbo M Ge, Ph.D||+86 10 50981788 ext email@example.com|
|JW Medical System|
|Beijing, Beijing, China, 100029|
|Contact: Wei M Fu, Bachelor +86 10 50981788 firstname.lastname@example.org|
|Contact: Hao M Lu, Ph.D +86 10 50981788 email@example.com|
|Principal Investigator: Junbo M Ge, Ph.D|
|Sub-Investigator: Lei M Ge, Ph.D|
|Sub-Investigator: Yong M Huo, Ph.D|
|Sub-Investigator: Jian an M Wang, Ph.D|
|Study Director:||Hao M Lu, Ph.D||Zhongshan hospital of ShangHai FuDan University|