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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01382043

Enrollment

Registered

2011-06-27

Start date

2009-06-30

Completion date

2011-01-31

Last updated

2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Coronary Angioplasty

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Countries

China

Outcome results