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Angiographic and IVUS Follow-up After Simultaneously Implanted Different Drug-eluting Stents in Same Individuals (AIFSIDDES)

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ClinicalTrials.gov Identifier: NCT01382043
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The safety and efficacy of drug-eluting stents (DES) with a biocompatible polymer have been demonstrated in randomized clinical trials as well as in real world practice. Theoretically, a new DES with a biodegradable polymer should reduce the incidence of late in-stent thrombosis, however, the long-term safety and efficacy of these stents remains unknown. This study was aimed to compare the safety and efficacy of the Excel DES with a biodegradable polymer to the Endeavor DES with a biocompatible polymer in same individuals.

Condition or disease
Percutaneous Coronary Angioplasty

Study Design

Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Study Start Date : June 2009
Primary Completion Date : September 2010
Study Completion Date : January 2011
Groups and Cohorts

Group/Cohort
Endeavor Segment group
Excel Segment Group


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patiemts who underwent simultaneous implantation of one or more Endeavor stents and one or more Excel stents during the same index procedure and were evaluated with coronary angiography and intravascular ultrasound (IVUS) at least one year post-procedure.
Criteria

Inclusion Criteria:

  • simultaneous implantation of one or more Endeavor stents and one or more Excel stents during the same index procedure
  • willing to be followed up with coronary angiography and intravascular ultrasound at least one year post-procedure.

Exclusion Criteria:

  • Patients were excluded from the study if they had more than two kinds of stents implanted or if the two study stents were implanted during separate interventional procedures or in coronary artery bridge vessel or restenotic lesions.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382043


Locations
China, Guangdong
Liuhuaqiao Hospital
Guangzhou, Guangdong, China, 510010
Sponsors and Collaborators
Liuhuaqiao Hospital
Investigators
Principal Investigator: Dingcheng Xiang, Dr. Liuhuaqiao Hospital
More Information

Responsible Party: Liujian, Liuhuaqiao Hospital
ClinicalTrials.gov Identifier: NCT01382043     History of Changes
Other Study ID Numbers: LHQ09-002
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Liuhuaqiao Hospital:
percutaneous coronary angioplasty
zotarolimus-eluting stent
sirolimus-eluting stent
biodegradable polymer
biocompatible polymer