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Trial record 3 of 660 for:    excel

EXCEL-II Stent Vesus EXCEL Stent to Treat the Patients With de Novo Coronary Artery Lesions. (CREDIT-II)

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ClinicalTrials.gov Identifier: NCT02057978
Recruitment Status : Enrolling by invitation
First Posted : February 7, 2014
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
JW Medical Systems Ltd

Brief Summary:
The purpose of this Randomized Study to evaluate the safety and efficacy of the Excel-II DES compared to the EXCEL DES in the treatment of patients with de novo coronary artery lesions.

Condition or disease Intervention/treatment
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Procedure: EXCEL DES implatation Procedure: EXCEL-II DES implantation

Detailed Description:

The primary end point is to observe in-stent late lumenn loss after 9 months of the stent implantation.

This study is based on non-inferior assumption (vs. EXCEL-II V EXCEL Stent), requring all of end points reach statictic significance.

Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.

Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems).

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used and normal ranges if relevant.

Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.

Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.

Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 416 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Prospective Multicenter Randomized Trial to Assess the Safety and Effectiveness of EXCEL-II Sirolimus Eluting Stent vs. EXCEL Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery Lesions .( CREDIT II Trial )
Study Start Date : November 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2019


Group/Cohort Intervention/treatment
EXCEL DES
Use EXCEL DES implatationas as control group,Implant DES for CAD cases
Procedure: EXCEL DES implatation
Implant DES for CAD cases
Other Name: Implant DES for CAD cases
EXCEL-II DES
EXCEL-II DES implantation as control group,Implant DES for CAD cases
Procedure: EXCEL-II DES implantation
Implant DES for CAD cases
Other Name: Implant EXCEL-II DES for CAD cases



Primary Outcome Measures :
  1. 9 months in-stent late lumen loss [ Time Frame: 9 months ]
    To observe in-stent late lumen loss after 9 months of stent implantation


Secondary Outcome Measures :
  1. 9-m in-segment diameter restenosis rate [ Time Frame: 9 months ]
    9-m in stent, proximal stent edge, the distal edge segment defined in the restenosis rate, 9-m after lesions within the segment late lumen loss percentage and the diameter of the restenosis degree

  2. Device success rates , lesion success rates , clinical success rates Device, lesion, & clinical success rates Device, lesion, & clinical success rates Target Lesion Failure [ Time Frame: 1m,6m,9m,12m,18m and annually to 5years ]
    Device oriented composite of cardiac death, MI, or ischemia-driven TLR at 1m, 6m, 12m,18m and annually up to 5 yrs

  3. Rate of stent thrombosis [ Time Frame: 1m,6m,9m,12m,18m and annually up to 5 yrs ]
    Definite and probable stent thrombosis according to ARC defination


Biospecimen Retention:   None Retained
Endpoint Classification: Safety/Efficacy Study Enrollment: 416 cases [Anticipated]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will plan for a total of 416 patients with primary, in situ coronary artery lesions (all of the patients was selected in different blood vessels, a total of up to two target disease Variable and each target lesion 1 stents, such as placing stents need more than one in the operation, require the use of the same brand of stents, mix does not recommend the same patients Other brand support, unless save extra stents.) Choose lesions reference diameter of 2.5 mm to 2.5 mm (visual), each lesion length 32 mm or less (visual), participants must conform to the standard can be selected.
Criteria

Inclusion criteria:

1.18yrs≤Age≤75yrs . 2.stability and unstable angina pectoris (AP), chronic myocardial infarction (OMI) or confirmed myocardial ischemia; 3.De novo lesion at native coronary artery(Up to two target lesions). 4.Lesion length ≤32mm. 5.RVD 2.5mm~4.0mm. 6.DS%≥70% by visual test. 7.Coronary artery bypass surgery (coronary artery bypass grafting) patients. 8.Subjects are willing to follow the specified requirements follow-up. 9.To understand the purpose of the trial and willing to sign informed consent and accept clinical follow-up.

Exclusion Criteria:

  1. AMI within 7 days.
  2. CTO (TIMI 0), the left main lesion, ostial lesion and transplant vascular lesions, the bifurcation lesion (reference collateral blood vessel diameter of 2.5 mm or higher), stent restenosis lesions and to deal with three pathological changes;
  3. Severe calcified lesion unable to predilate.
  4. The distortion of the stent was hampered by lesions.
  5. NYHA≥Ⅲ or LVEF<40%.
  6. Prior PCI within 1 year.
  7. Pregnancy or lactation, and planning pregnancy or lactation.
  8. Subjects have bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue to take DAPT at least 1 year.
  9. There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (< 1 year).
  10. To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
  11. Serious liver and kidney function are not complete subject(ALT and AST were three times greater than the upper limit of normal).
  12. Before enrolling to participate in other clinical trials and not reached the primary endpoint.
  13. Non-compliant subject and could not finish the trial in accordance with the requirements of the subjects.

Information from the National Library of Medicine

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): NCT02057978


Locations
China, Liaoning
Shenyang Northern Hospital
Shenyang, Liaoning, China, 110015
Sponsors and Collaborators
JW Medical Systems Ltd
Investigators
Principal Investigator: Han Yaling, PhD Shenyang Northern Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JW Medical Systems Ltd
ClinicalTrials.gov Identifier: NCT02057978     History of Changes
Other Study ID Numbers: CREDIT-II-131105
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014

Keywords provided by JW Medical Systems Ltd:
Late Lumen Loss
MACE
Death
TLF
Thrombosis(definite or probable )

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents