NCT00385905

Brief Summary

The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

October 11, 2006

Status Verified

October 1, 2006

First QC Date

October 10, 2006

Last Update Submit

October 10, 2006

Conditions

Coronary Stenosis

Outcome Measures

Primary Outcomes (1)

  • 12-month MACE

Secondary Outcomes (2)

  • 30-day or 6-month MACE

  • 6 to 9-month restenosis rate by SCA follow-up

Interventions

Excel Drug-eluting stentDEVICE

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who should fulfill with criteria of implanting Excel stents.
  • Each patient enrolled is only allowed to implant Excel stents.
  • Each patient are not allowed to be implanted more than 6 Excel stents.Also, 3 over-lapped stents are not allowed to be implanted in the same vessel(3-5mm overlapping needed; length of stents totally are not allowed to be over 80mm; fully post-dilated is essential for overlapping).
  • Patients acknowlegement to the trial is essential.

You may not qualify if:

  • AMI withine 1 week.
  • Patients who do not suitable to Excel stenting.(For example, non-tolerant to anti-platelet drug or cardiac/non-cardiac surgery undergoing recently.)
  • Patients who have multiple branch lesions can not apply single Excel stenting.
  • Patients who refuse to sign the Trial Acknowledgement.
  • Patients with intra-stent restenosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenyang Nothern Hospital

Shenyang, Liaoning, 110016, China

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Yaling Han, Ph.D.

    Shenyang Northern Hospital

    STUDY CHAIR

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

October 10, 2006

First Posted

October 11, 2006

Study Start

February 1, 2006

Study Completion

January 1, 2007

Last Updated

October 11, 2006

Record last verified: 2006-10

Locations

CN(1)