CClinicalTrials.gg
Sign In
CompletedNCT00331578CREATEUpdated Jan 21, 2009

Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent

A Phase 4 interventional study of Excel drug-eluting coronary artery stent in AMI, sponsored by JW Medical Systems Ltd. Completed. Per ClinicalTrials.gov, last updated 2009-01-21.

Sponsored by JW Medical Systems Ltd · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
2,077
Allocation
Non-randomized
Sex
All
01

Study summary

The trial aims to evaluate 12-month long-term efficiency of Excel stent in the treatment of coronary heart disease and inhibition of restenosis after coronary artery stenting as well as a 12 months' long-term safety after the cessation of clopidogrel as an anti-platelet drugs used for 6 months after the implantation of degradable drug coating stent.

02

Conditions studied

  • AMI
03

In context

Lead sponsor

JW Medical Systems Ltd is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient who should be full fill the criteria of using Excel stent.
  2. Each included patient should allowed to use Excel stent.
  3. Complete revascularization can be achieved through one invasive operation.

Exclusion criteria

Exclusion Criteria:

  1. Patient do not suitable to use Excel stent, for example, not tolerant to anti-platelet drug or undergo cardiac/non-cardiac surgery recently.
  2. Patient with multiple branch lesions, thus the single Excel stent cannot resolve the condition.
  3. NYH Cardiac functional grading>3 or Echocardiography LVEF\<0.3.
  4. Patient with complete revascularization cannot be resolved by one operation.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2,077 participants (actual)

Interventions

  • DeviceExcel drug-eluting coronary artery stent
06

What researchers measure

Primary outcomes

  1. MACE(Major adverse cardiac events)

    Time frame: 12 months

Secondary outcomes

  1. MACE

    Time frame: 30 days and 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Li Y, Han Y, Zhang L, Jing Q, Wang X, Yan G, Ma Y, Wang G, Wang S, Chen X, Yang L, Zhu G, Liu H, Jiang T. Clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in patients with diabetes mellitus insight from the 4-year results of the create study. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1127-33. doi: 10.1002/ccd.24649. Epub 2013 Feb 26. PubMed 22945767 ↗
  • Han Y, Jing Q, Xu B, Yang L, Liu H, Shang X, Jiang T, Li Z, Zhang H, Li H, Qiu J, Liu Y, Li Y, Chen X, Gao R; CREATE (Multi-Center Registry of Excel Biodegradable Polymer Drug-Eluting Stents) Investigators. Safety and efficacy of biodegradable polymer-coated sirolimus-eluting stents in "real-world" practice: 18-month clinical and 9-month angiographic outcomes. JACC Cardiovasc Interv. 2009 Apr;2(4):303-9. doi: 10.1016/j.jcin.2008.12.013. PubMed 19463441 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00331578
Lead sponsor
JW Medical Systems Ltd
First posted
May 31, 2006
Start date
Jun 2006
Completion
Dec 2006
Last update
Jan 21, 2009

Study contacts

Yaling Han, Ph.D.
principal investigator · Shenyang Northern Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

JW Medical Systems Ltd

Start the discussion