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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
History of Changes
  Purpose

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
Percutaneous Coronary Angioplasty

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Further study details as provided by Liuhuaqiao Hospital:

Enrollment: 48
Study Start Date: June 2009
Study Completion Date: January 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Endeavor Segment group
Excel Segment Group

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Liujian, Liuhuaqiao Hospital
ClinicalTrials.gov Identifier: NCT01382043     History of Changes
Other Study ID Numbers: LHQ09-002
Study First Received: June 23, 2011
Last Updated: June 24, 2011
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013