Excel Drug-Eluting Stent Pilot Clinical Registry - Full Text View

Purpose

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.

Condition	Intervention	Phase
Coronary Stenosis	Device: Excel Drug-eluting stent	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Excel Drug-Eluting Stent Pilot Clinical Registry

Further study details as provided by JW Medical Systems Ltd:

Primary Outcome Measures:

12-month MACE

Secondary Outcome Measures:

30-day or 6-month MACE
6 to 9-month restenosis rate by SCA follow-up

Estimated Enrollment:	100
Study Start Date:	February 2006
Estimated Study Completion Date:	January 2007

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385905

Locations


China, Liaoning
	Shenyang Nothern Hospital
	Shenyang, Liaoning, China, 110016

Sponsors and Collaborators

JW Medical Systems Ltd

Investigators


Study Chair:	Yaling Han, Ph.D.	Shenyang Northern Hospital

More Information

Study ID Numbers:	H-2006-2
First Received:	October 10, 2006
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00385905
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Coronary Disease

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Constriction, Pathologic

Ischemia

Coronary Stenosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	JW Medical Systems Ltd
Information provided by:	JW Medical Systems Ltd
ClinicalTrials.gov Identifier:	NCT00385905