XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01086228
First received: March 11, 2010
Last updated: April 4, 2014
Last verified: April 2014

March 11, 2010
April 4, 2014
March 2010
June 2012   (final data collection date for primary outcome 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • (This study has no primary outcome measure. All observations are of equal weight) Stent thrombosis as per ARC definition. [ Time Frame: 1, 2, 3, 4, and 5 years post index procedure ] [ Designated as safety issue: Yes ]
  • Information on and the frequency of adverse events caused by antiplatelet therapy [ Time Frame: 1, 2, 3, 4, and 5 years post index procedure ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01086228 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Device malfunctions [ Time Frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: 240 days and at 1,2,3 (per CEC adjudication), 4 and 5 (as site reported) years post procedure ] [ Designated as safety issue: Yes ]
  • Reference vessel diameter (RVD) and minimal lumen diameter (MLD) and % diameter stenosis (DS) [ Time Frame: pre-procedure and post-procedure ] [ Designated as safety issue: No ]
  • In-stent late loss (LL) and in-stent % DS [ Time Frame: 240 days ] [ Designated as safety issue: No ]
  • In-segment LL and in-segment % DS [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 24 hours (acute) and 30 days (subacute) post procedure ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and any MI (Q wave or Non-Q wave) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Composite rate of any death and any MI (QMI or NQMI) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Composite rate of any death, any MI (QMI or NQMI), and any coronary repeat revascularization (PCI or CABG, clinically indicated [CI] vs. non-clinically indicated [non-CI]) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • 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, 4, and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Any death (cardiac death, vascular death, or non-cardiovascular death) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Any MI (QMI or NQMI) [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • 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, 4, and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Administration and discontinuation of predefined antiplatelet therapy [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Device malfunctions [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: 240 days and at 1, 2, 3, 4, and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • Reference vessel diameter (RVD) and minimal lumen diameter (MLD) and % diameter stenosis (DS) [ Time Frame: pre-procedure and post-procedure ] [ Designated as safety issue: No ]
  • In-stent late loss (LL) and in-stent % DS [ Time Frame: 240 days ] [ Designated as safety issue: No ]
  • In-segment LL and in-segment % DS [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
Not Provided

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.

The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Only patients in Japan, who are eligible to receive treatment for coronary arteries using the XIENCE V / PROMUS Everolimus-Eluting Stent System are to be enrolled.

  • Angina
  • Chronic Coronary Occlusion
  • Stent Thrombosis
  • Vascular Disease
  • Myocardial Ischemia
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis
Device: XIENCE V / PROMUS stent placement
Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
XIENCE V / PROMUS
Only the patients treated with the XIENCE V stent(s) or PROMUS stent(s) during the index procedure will be analyzed.
Intervention: Device: XIENCE V / PROMUS stent placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2032
August 2016
June 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01086228
09-384
No
Abbott Vascular
Abbott Vascular
Not Provided
Study Director: Gary Thompson Abbott Vascular
Abbott Vascular
April 2014

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