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

NCT01086228 | Completed Results

• 1 other identifier: 09-384
• Study Type: observational
• Target: 2,010
• Locations: 1 country
• Sites: 47

Brief 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.

Conditions

Angina; Chronic Coronary Occlusion; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Keywords

Drug eluting stents; Stents; Angioplasty

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Stent Thrombosis (ST) as Per ARC Definition

  Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise\&fall in cardiac biomarkers * Non-occlusive \&occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: * Unexplained death within first 30 days * Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST\&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up

  Post Procedure to 1 Year

• Number of Participants With Stent Thrombosis (ST) as Per ARC Definition

  Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise\&fall in cardiac biomarkers * Non-occlusive \&occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: * Unexplained death within first 30 days * Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST\&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up

  From 1 Year to 2 Years

• Number of Participants With Stent Thrombosis (ST) as Per ARC Definition

  Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise\&fall in cardiac biomarkers * Non-occlusive \&occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: * Unexplained death within first 30 days * Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST\&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up

  From 2 years to 3 years

Secondary Outcomes (48)

• Number of Participants With Adverse Events Related to Anti-platelet Medication

  From post-procedure to 1 year

• Number of Participants With Adverse Events Related to Anti-platelet Medication

  From 1 year to 2 years

• Number of Participants With Adverse Events Related to Anti-platelet Medication

  From 2 years to 3 years

• Number of Participants With Adverse Events Related to Anti-platelet Medication

  From 3 years to 4 years

• Number of Participants With Adverse Events Related to Anti-platelet Medication

  From 4 years to 5 years

Study Arms (1)

XIENCE V / PROMUS stent

Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.

Device: XIENCE V / PROMUS stent

Interventions

XIENCE V / PROMUS stent DEVICE

Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.

XIENCE V / PROMUS stent

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.

You may not qualify if:

• Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (47)

Site Reference ID/Investigator# 104727

Aichi, Japan

Location

Site Reference ID/Investigator# 113428

Aichi, Japan

Location

Site Reference ID/Investigator# 115745

Aichi, Japan

Location

Site Reference ID/Investigator# 104424

Chiba, Japan

Location

Site Reference ID/Investigator# 113645

Chiba, Japan

Location

Site Reference ID/Investigator# 105015

Ehime, Japan

Location

Site Reference ID/Investigator# 105148

Fukuoka, Japan

Location

Site Reference ID/Investigator# 105177

Fukuoka, Japan

Location

Site Reference ID/Investigator# 104677

Gifu, Japan

Location

Site Reference ID/Investigator# 104365

Gunma, Japan

Location

Site Reference ID/Investigator# 105038

Hiroshima, Japan

Location

Site Reference ID/Investigator# 105043

Hiroshima, Japan

Location

Site Reference ID/Investigator# 104236

Hokkaido, Japan

Location

Site Reference ID/Investigator# 105963

Hyōgo, Japan

Location

Site Reference ID/Investigator# 104326

Ibaraki, Japan

Location

Site Reference ID/Investigator# 104606

Ishikawa, Japan

Location

Site Reference ID/Investigator# 104607

Ishikawa, Japan

Location

Site Reference ID/Investigator# 104528

Kanagawa, Japan

Location

Site Reference ID/Investigator# 104536

Kanagawa, Japan

Location

Site Reference ID/Investigator#104563

Kanagawa, Japan

Location

Site Reference ID/Investigator# 104837

Kyoto, Japan

Location

Site Reference ID/Investigator# 104838

Kyoto, Japan

Location

Site Reference ID/Investigator# 104843

Kyoto, Japan

Location

Site Reference ID/Investigator# 104844

Kyoto, Japan

Location

Site Reference ID/Investigator# 104850

Kyoto, Japan

Location

Site Reference ID/Investigator# 104658

Nagano, Japan

Location

Site Reference ID/Investigator# 104990

Nara, Japan

Location

Site Reference ID/Investigator# 105027

Okayama, Japan

Location

Site Reference ID/Investigator# 105296

Okinawa, Japan

Location

Site Reference ID/Investigator# 104864

Osaka, Japan

Location

Site Reference ID/Investigator# 104898

Osaka, Japan

Location

Site Reference ID/Investigator# 104906

Osaka, Japan

Location

Site Reference ID/Investigator# 114863

Osaka, Japan

Location

Site Reference ID/Investigator# 104407

Saitama, Japan

Location

Site Reference ID/Investigator# 106044

Saitama, Japan

Location

Site Reference ID/Investigator# 104697

Shizuoka, Japan

Location

Site Reference ID/Investigator# 104356

Tochigi, Japan

Location

Site Reference ID/Investigator# 105092

Tokushima, Japan

Location

Site Reference ID/Investigator# 104448

Tokyo, Japan

Location

Site Reference ID/Investigator# 104454

Tokyo, Japan

Location

Site Reference ID/Investigator# 104473

Tokyo, Japan

Location

Site Reference ID/Investigator# 104497

Tokyo, Japan

Location

Site Reference ID/Investigator# 104510

Tokyo, Japan

Location

Site Reference ID/Investigator# 104514

Tokyo, Japan

Location

Site Reference ID/Investigator#104481

Tokyo, Japan

Location

Site Reference ID/Investigator # 104285

Yamagata, Japan

Location

Site Reference ID/Investigator# 104294

Yamagata, Japan

Location

Related Publications (3)

• Aoki J, Kozuma K, Awata M, Nanasato M, Shiode N, Tanabe K, Yamaguchi J, Kusano H, Nie H, Kimura T; XIEVCE V/PROMUS PMS Investigators. Five-year clinical outcomes of everolimus-eluting stents from the post marketing study of CoCr-EES (XIENCE V/PROMUS) in Japan. Cardiovasc Interv Ther. 2019 Jan;34(1):40-46. doi: 10.1007/s12928-018-0515-z. Epub 2018 Feb 26.

  PMID: 29484580 DERIVED

• Shiode N, Kozuma K, Aoki J, Awata M, Nanasato M, Tanabe K, Yamaguchi J, Kusano H, Nie H, Kimura T; XIEVCE V/Promus PMS Investigators. The impact of coronary calcification on angiographic and 3-year clinical outcomes of everolimus-eluting stents: results of a XIENCE V/PROMUS post-marketing surveillance study. Cardiovasc Interv Ther. 2018 Oct;33(4):313-320. doi: 10.1007/s12928-017-0484-7. Epub 2017 Jul 19.

  PMID: 28726115 DERIVED

• Aoki J, Kozuma K, Awata M, Nanasato M, Shiode N, Tanabe K, Yamaguchi J, Kusano H, Nie H, Kimura T; XIEVCE V/PROMUS PMS Investigators. Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan. Circ J. 2016;80(4):906-12. doi: 10.1253/circj.CJ-15-1181. Epub 2016 Jan 27.

  PMID: 26821583 DERIVED

MeSH Terms

Conditions

Angina Pectoris; Vascular Diseases; Myocardial Ischemia; Coronary Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: David R Rutledge
• Organization: Abbott Vascular

david.rutledge@av.abbott.com

(408) 845-3820

Study Officials

• Gary Thompson

  Abbott Medical Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2016
• Last Updated: February 19, 2018
• Results First Posted: February 19, 2018

Record last verified: 2017-08

Locations

JP (47)