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

NCT01382043 | Completed

• 1 other identifier: LHQ09-002
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Angioplasty

Keywords

percutaneous coronary angioplasty; zotarolimus-eluting stent; sirolimus-eluting stent; biodegradable polymer; biocompatible polymer

Study Arms (2)

Endeavor Segment group

Excel Segment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liuhuaqiao Hospital: lead

Study Sites (1)

Liuhuaqiao Hospital

Guangzhou, GD, 510010, China

Location

Study Officials

• Dingcheng Xiang, Dr.

  Liuhuaqiao Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 21, 2018

Record last verified: 2011-06

Locations

CN (1)