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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by JW Medical Systems Ltd
Sponsor:
Information provided by (Responsible Party):
JW Medical Systems Ltd
ClinicalTrials.gov Identifier:
NCT02027870
First received: January 2, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

The study aims to further assess the safety, efficacy and the performance of its delivery system of the new generation Sirolimus-eluting stent of JWMS up to five years.


Condition Intervention Phase
Coronary Artery Disease
Device: EXCEL-II biodegradable polymer sirolimus-eluting stent
Phase 2
Phase 3

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Prospective Multicenter Single-Arm Observational Registry Study to Assess the Safety and Efficacy of EXCEL-II With Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery . (CREDIT-III Trial)

Resource links provided by NLM:


Further study details as provided by JW Medical Systems Ltd:

Primary Outcome Measures:
  • The Target Lesion Failure(TLF) as the primary endpoint at 12-month [ Time Frame: 12months ] [ Designated as safety issue: Yes ]
    Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure


Secondary Outcome Measures:
  • Stent implantation success rate [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • TLF, cardiovascular composite endpoints, ARC defined stent thrombosis [ Time Frame: 30 days, 6 months, and 2-5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

According to the CREATE (Multi - Center Registry of Excel Biodegradable Polymer Drug Eluting Stent) registration results show that ExcelTM drug-eluting stents implanted an average of 12 months, target lesion (TLF) the failure rate of 6.7%.Will this study expected target lesion group stent failure rate estimate of 6.7%, the target is 9.5%;Test hypothesis: bilateral 0.05% 0.05%, master degree, clinical follow-up requirements is more than 95%, this research need at least 829 patients, remove the CREDIT II randomized controlled study can provide the number of cases of test group 208 examples, this study still need to be included in the 621 patients.


Estimated Enrollment: 621
Study Start Date: January 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
EXCEL-II DES
Using EXCEL-II biodegradable polymer sirolimus-eluting stent treating CAD
Device: EXCEL-II biodegradable polymer sirolimus-eluting stent
EXCEL-II biodegradable polymer sirolimus-eluting stent implantation

Detailed Description:
  1. A prospective, a single set, multicenter clinical trial;
  2. The primary in situ in patients with coronary heart disease;
  3. The center of: 28 (the actual number of center shall prevail);The plan selected 621 patients;(where the total number of cases in 2.25 mm specification not less than 30 cases, 5 cases each specification of not less than 2.25 mm.)
  4. Clinical follow-up time points: 1 months, 6 months, 12 months and 18 months of a year and 2 years to 5 years follow-up; This test by an independent coronary angiography core laboratories, data management and statistical center, clinical end points to judge committee and clinical monitoring of all relevant clinical and imaging data collecting, sorting, statistical analysis and judgement.All the selected patients within five years continuous follow-up tracking (phone or outpatient follow-up), to observe the happening of adverse events to the forward of the second generation of EXCEL drug-eluting stents (des) system security to make more accurate and credible evaluation.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

the Patients With de Novo Coronary Artery Lesions

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 four target lesions). 4.Lesion length ≤60mm. 5.RVD 2.25mm~4.0mm. 6.DS%≥70% by visual estimation. 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 testing, voluntary and signed informed consent, willing to accept the imaging and clinical follow-up of subjects.

Exclusion Criteria:

  1. AMI within 7 days.
  2. Left main lesion, transplant vasculopathy and stent restenosis lesion;
  3. Severe calcified lesion unable to predilate.
  4. The distortion of the stent was hampered by lesions.
  5. NYHA≥Ⅲ or LVEF<35%.
  6. Prior stenting within 1 year.
  7. Pregnancy or lactation, and plan in postoperative pregnancy or lactation.
  8. Subjects had bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue DAPT healers 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 is not complete person(ALT and AST were three times greater than the upper limit of normal).
  12. Rounding out the top participated in other clinical trials have not reached the main research the finish time limit.
  13. The researchers determine adherence is poor, could not finish my study in accordance with the requirements of the subjects.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027870

Contacts
Contact: gangtao wang +86 010 68068918 gangtao.wang@jwmsgrp.com
Contact: yan lin +86 010 68068918

Locations
China, Liaoning
Shenyang Northern Hospital Recruiting
Shenyang, Liaoning, China, 110015
Contact: geng wang, PhD    +86 13309886393    wanggeng69@hotmail.com   
Contact: he zhou    +86 13309888541    fengying_6@163.com   
Sub-Investigator: Wang Geng, PhD         
Sponsors and Collaborators
JW Medical Systems Ltd
Investigators
Principal Investigator: yaling Han, MD Shen yang Northern hospital
  More Information

No publications provided

Responsible Party: JW Medical Systems Ltd
ClinicalTrials.gov Identifier: NCT02027870     History of Changes
Other Study ID Numbers: CREDIT-III-131113
Study First Received: January 2, 2014
Last Updated: January 2, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by JW Medical Systems Ltd:
DES
CAD
EXCEL-II
JWMS
PCI

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chlorhexidine
Chlorhexidine gluconate
Sirolimus
Everolimus
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014