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

This study has been completed.
Sponsor:
Information provided by:
Liuhuaqiao Hospital
ClinicalTrials.gov Identifier:
NCT01382043
First received: June 23, 2011
Last updated: June 24, 2011
Last verified: June 2011

June 23, 2011
June 24, 2011
June 2009
September 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01382043 on ClinicalTrials.gov Archive Site
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Angiographic and IVUS Follow-up After Simultaneously Implanted Different Drug-eluting Stents in Same Individuals (AIFSIDDES)
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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.

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Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Non-Probability Sample

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.

Percutaneous Coronary Angioplasty
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  • Endeavor Segment group
  • Excel Segment Group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2011
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01382043
LHQ09-002
No
Liujian, Liuhuaqiao Hospital
Liuhuaqiao Hospital
Not Provided
Principal Investigator: Dingcheng Xiang, Dr. Liuhuaqiao Hospital
Liuhuaqiao Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP