- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00973375
Angiographic and Intravascular Ultrasound (IVUS) Follow-up After Simultaneously Implanted Different Drug-eluting Stents in Same Individuals (AIFSIDDES)
September 8, 2009 updated by: Liuhuaqiao Hospital
The purpose of this study is to investigate if there is any different follow-up results by angiography and IVUS between two different drug-eluting stents after implanted simultaneously in same individuals.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510010
- Recruiting
- Liuhuaqiao Hospital
-
Contact:
- Dingcheng Xiang, MD, Ph.D
- Phone Number: +86-20-3665 3325
- Email: dcxiang@foxmail.com
-
Principal Investigator:
- Dingcheng Xiang, MD, Ph.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
These patients who received two kinds of drug-eluting stent (Endeavor and Excel) im simultaneously.
Description
Inclusion Criteria:
- These patients who received two kinds of drug-eluting stent (Endeavor and Excel) im simultaneously.
Exclusion Criteria:
- Dual anti-platelet therapy less than 12 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Endeavor group and Excel group
Endeavor group: measurements from the vessels implanted Endeavor stent(s).
Excel group: measurements from the vessels implanted Excel stent(s).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Segment and instent restenosis measured by coronary angiography and IVUS.
Time Frame: at 12 months after implantation
|
at 12 months after implantation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Uncovered and malposition of stent.
Time Frame: at 12 months after implantation.
|
at 12 months after implantation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Waseda K, Miyazawa A, Ako J, Hasegawa T, Tsujino I, Sakurai R, Yock PG, Honda Y, Kandzari DE, Leon MB, Fitzgerald PJ; ENDEAVOR IV Trial Investigators. Intravascular ultrasound results from the ENDEAVOR IV trial: randomized comparison between zotarolimus- and paclitaxel-eluting stents in patients with coronary artery disease. JACC Cardiovasc Interv. 2009 Aug;2(8):779-84. doi: 10.1016/j.jcin.2009.05.015.
- Lee CH, Zhang J, Kailasam A, Tai BC, Ye F, Low AF, Hou X, Hay ET, Teo SG, Lim YT, Chen S, Tan HC. An intravascular ultrasound study of Cypher, Taxus, and endeavor stents on relation between neointimal proliferation and residual plaque burden. J Interv Cardiol. 2008 Dec;21(6):519-27. doi: 10.1111/j.1540-8183.2008.00397.x. Epub 2008 Oct 21.
- Miyazawa A, Ako J, Hongo Y, Hur SH, Tsujino I, Courtney BK, Hassan AH, Kandzari DE, Honda Y, Fitzgerald PJ; ENDEAVOR III Investigators. Comparison of vascular response to zotarolimus-eluting stent versus sirolimus-eluting stent: intravascular ultrasound results from ENDEAVOR III. Am Heart J. 2008 Jan;155(1):108-13. doi: 10.1016/j.ahj.2007.08.008. Epub 2007 Sep 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Study Registration Dates
First Submitted
September 8, 2009
First Submitted That Met QC Criteria
September 8, 2009
First Posted (Estimate)
September 9, 2009
Study Record Updates
Last Update Posted (Estimate)
September 9, 2009
Last Update Submitted That Met QC Criteria
September 8, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- LHQ09-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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