Overview

This trial is active, not recruiting.

Conditions angina, chronic coronary occlusion, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis, coronary disease, coronary artery disease, coronary restenosis
Treatment xience v / promus stent
Sponsor Abbott Vascular
Start date March 2010
End date June 2012
Trial size 2032 participants
Trial identifier NCT01086228, 09-384

Summary

The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
xience v / promus stent
Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.

Primary Outcomes

Measure
(This study has no primary outcome measure. All observations are of equal weight) Stent thrombosis as per ARC definition.
time frame: 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure
Information on and the frequency of adverse events caused by antiplatelet therapy
time frame: 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure

Secondary Outcomes

Measure
Composite rate of cardiac death and any MI (Q wave or Non-Q wave)
time frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure
Composite rate of any death, any MI (QMI or NQMI), and any coronary repeat revascularization (clinically indicated [CI] vs. non-clinically indicated [non-CI])
time frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure
Composite rate of any death, any MI (QMI or NQMI), and any coronary repeat revascularization (PCI or CABG, CI vs. non-CI)
time frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure
Composite rate of cardiac death, any target vessel MI (QMI or NQMI), and TLR (PCI or CABG, CI vs. non-CI)
time frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure
Any death (cardiac death, vascular death, or non-cardiovascular death)
time frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure
Any MI (QMI or NQMI)
time frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure
Any repeat coronary revascularization (TLR, TVR, or non-target vessel TVR by PCI or CABG, CI vs. non-CI)
time frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure
Administration and discontinuation of predefined antiplatelet therapy
time frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure
Device malfunctions
time frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure
Serious adverse events
time frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure
Reference vessel diameter (RVD) and minimal lumen diameter (MLD) and % diameter stenosis (DS)
time frame: pre-procedure and post-procedure
In-stent late loss (LL) and in-stent % DS
time frame: 240 days
In-segment LL and in-segment % DS
time frame: 240 days
Stent thrombosis
time frame: 24 hours (acute) and 30 days (subacute) post procedure

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure. Exclusion Criteria: - Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.

Additional Information

Official title XIENCE V/PROMUS Everolimus-Eluting Stent System Japan Post-marketing Surveillance Protocol
Description The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Abbott Vascular.