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CompletedNCT02027870CREDIT-IIIUpdated Apr 26, 2023

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

An observational study in Coronary Artery Disease, sponsored by JW Medical Systems Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-26.

Sponsored by JW Medical Systems Ltd (part of Blue Sail Medical Co., Ltd.) · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
625
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Coronary Artery Disease

Keywords

  • DES
  • CAD
  • EXCEL-II
  • JWMS
  • PCI
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's enrollment of 625 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

JW Medical Systems Ltd is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

First submitted before JW Medical Systems Ltd became part of Blue Sail Medical Co., Ltd..

Browse JW Medical Systems Ltd studies →All Blue Sail Medical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

the Patients With de Novo Coronary Artery Lesions

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
625 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
None retained

Groups and cohorts

  • EXCEL-II DES

    Using EXCEL-II biodegradable polymer sirolimus-eluting stent treating CAD

    Device: EXCEL-II biodegradable polymer sirolimus-eluting stent

Interventions

  • DeviceEXCEL-II biodegradable polymer sirolimus-eluting stent

    EXCEL-II biodegradable polymer sirolimus-eluting stent implantation

06

What researchers measure

Primary outcomes

  1. The Target Lesion Failure(TLF) as the primary endpoint at 12-month

    Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure

    Time frame: 12months

Secondary outcomes

  1. Stent implantation success rate

    Time frame: 5 Years

  2. TLF, cardiovascular composite endpoints, ARC defined stent thrombosis

    Time frame: 30 days, 6 months, and 2-5 years

07

Study locations

1 site
  • Shenyang Northern Hospital
    Shenyang, Liaoning 110015, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2014 to primary completion in Jul 2017, 42 months.

Of 131 industry-sponsored observational studies under Coronary Artery Disease, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 42. This study's 42 months is above that.

Counting every sponsor, half of 857 studies reached it within 43 months; a quarter within 22 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2014
First posted
Jan 6, 2014
StartActual
Jan 8, 2014
Primary completionActual
Jul 30, 2017
CompletionActual
Nov 7, 2019
Last update
Apr 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02027870
Lead sponsor
JW Medical Systems Ltd
Responsible party
Sponsor
First posted
Jan 6, 2014
Start date
Jan 8, 2014
Primary completion
Jul 30, 2017
Completion
Nov 7, 2019
Last update
Apr 26, 2023

Study contacts

yaling Han, MD
principal investigator · Shen yang Northern hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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