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
  Purpose

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.


Condition Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • (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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2032
Study Start Date: March 2010
Estimated Study Completion Date: August 2016
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
XIENCE V / PROMUS
Only the patients treated with the XIENCE V stent(s) or PROMUS stent(s) during the index procedure will be analyzed.
Device: XIENCE V / PROMUS stent placement
Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086228

Locations
Japan
Site Reference ID/Investigator# 113428
Aichi, Japan
Site Reference ID/Investigator# 115745
Aichi, Japan
Site Reference ID/Investigator# 104727
Aichi, Japan
Site Reference ID/Investigator# 104424
Chiba, Japan
Site Reference ID/Investigator# 113645
Chiba, Japan
Site Reference ID/Investigator# 105015
Ehime, Japan
Site Reference ID/Investigator# 105177
Fukuoka, Japan
Site Reference ID/Investigator# 105148
Fukuoka, Japan
Site Reference ID/Investigator# 104677
Gifu, Japan
Site Reference ID/Investigator# 104365
Gunma, Japan
Site Reference ID/Investigator# 105038
Hiroshima, Japan
Site Reference ID/Investigator# 105043
Hiroshima, Japan
Site Reference ID/Investigator# 104236
Hokkaido, Japan
Site Reference ID/Investigator# 105963
Hyogo, Japan
Site Reference ID/Investigator# 104326
Ibaraki, Japan
Site Reference ID/Investigator# 104606
Ishikawa, Japan
Site Reference ID/Investigator# 104607
Ishikawa, Japan
Site Reference ID/Investigator# 104536
Kanagawa, Japan
Site Reference ID/Investigator# 104528
Kanagawa, Japan
Site Reference ID/Investigator#104563
Kanagawa, Japan
Site Reference ID/Investigator# 104850
Kyoto, Japan
Site Reference ID/Investigator# 104844
Kyoto, Japan
Site Reference ID/Investigator# 104837
Kyoto, Japan
Site Reference ID/Investigator# 104843
Kyoto, Japan
Site Reference ID/Investigator# 104838
Kyoto, Japan
Site Reference ID/Investigator# 104658
Nagano, Japan
Site Reference ID/Investigator# 104990
Nara, Japan
Site Reference ID/Investigator# 105027
Okayama, Japan
Site Reference ID/Investigator# 105296
Okinawa, Japan
Site Reference ID/Investigator# 104906
Osaka, Japan
Site Reference ID/Investigator# 104864
Osaka, Japan
Site Reference ID/Investigator# 114863
Osaka, Japan
Site Reference ID/Investigator# 104898
Osaka, Japan
Site Reference ID/Investigator# 104407
Saitama, Japan
Site Reference ID/Investigator# 106044
Saitama, Japan
Site Reference ID/Investigator# 104697
Shizuoka, Japan
Site Reference ID/Investigator# 104356
Tochigi, Japan
Site Reference ID/Investigator# 105092
Tokushima, Japan
Site Reference ID/Investigator# 104510
Tokyo, Japan
Site Reference ID/Investigator# 104514
Tokyo, Japan
Site Reference ID/Investigator#104481
Tokyo, Japan
Site Reference ID/Investigator# 104448
Tokyo, Japan
Site Reference ID/Investigator# 104497
Tokyo, Japan
Site Reference ID/Investigator# 104454
Tokyo, Japan
Site Reference ID/Investigator# 104473
Tokyo, Japan
Site Reference ID/Investigator # 104285
Yamagata, Japan
Site Reference ID/Investigator# 104294
Yamagata, Japan
Sponsors and Collaborators
Abbott Vascular
Investigators
Study Director: Gary Thompson Abbott Vascular
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01086228     History of Changes
Other Study ID Numbers: 09-384
Study First Received: March 11, 2010
Last Updated: April 4, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Abbott Vascular:
Drug eluting stents
Stents
Angioplasty

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Thrombosis
Vascular Diseases
Coronary Occlusion
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Embolism and Thrombosis

ClinicalTrials.gov processed this record on August 21, 2014