NCT00331578

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,077

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

First QC Date

May 30, 2006

Last Update Submit

January 19, 2009

Conditions

AMI

Outcome Measures

Primary Outcomes (1)

  • MACE(Major adverse cardiac events)

    12 months

Secondary Outcomes (1)

  • MACE

    30 days and 6 months

Interventions

Excel drug-eluting coronary artery stentDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 22945767DERIVED

  • 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.

    PMID: 19463441DERIVED

Study Officials

  • Yaling Han, Ph.D.

    Shenyang Northern Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

June 1, 2006

Study Completion

December 1, 2006

Last Updated

January 21, 2009

Record last verified: 2009-01