Excel Drug-Eluting Stent Pilot Clinical Registry

Coronary Stenosis Clinical Trial

Official title:

Excel Drug-Eluting Stent Pilot Clinical Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385905
• Other study ID #: H-2006-2
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2006
• Last updated: October 10, 2006
• Start date: February 2006
• Est. completion date: January 2007

Study information

• Verified date: October 2006
• Source: JW Medical Systems Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

30-day, 6-month, and 12-month clinical follow-up and 6 to 9-month IVUS or SCA follow-up to measure 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

Device:
• Excel Drug-eluting stent

Locations

Country	Name	City	State
China	Shenyang Nothern Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
JW Medical Systems Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month MACE
Secondary	30-day or 6-month MACE
Secondary	6 to 9-month restenosis rate by SCA follow-up