XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE PRIME SV Japan PMS)

NCT02513719 | Completed Results DMC

• 1 other identifier: 12-303
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 33

Brief Summary

The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.

Conditions

Ischemic Heart Disease; Angina Pectoris; Coronary Artery Disease; Coronary Artery Occlusion; Myocardial Ischemia

Keywords

drug eluting stent; stent; real world

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Stent Thrombosis: Acute

  Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timing: Acute stent thrombosis: 0 to 24 hours after stent implantation

  0-24 hours post stent implantation

• Number of Participants With Stent Thrombosis: Subacute

  Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Subacute stent thrombosis : \>24 hours to 30 days after stent implantation

  >24 hours to 30 days post stent implantation

• Number of Participants With Stent Thrombosis: Late

  Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Late stent thrombosis : \>30 days to 1 year after stent implantation

  30 days to 1 year post stent implantation

Secondary Outcomes (94)

• Number of Participants With Stent Thrombosis: Very Late

  >1 year post stent implantation

• Percent Diameter Stenosis (%DS)

  Pre-procedure

• Percent Diameter Stenosis (%DS)

  post procedure (on day 0)

• Percent Diameter Stenosis (%DS)

  8 months

• Success Rate: Percentage of Devices With Implant Success

  < or = 1 day

Study Arms (1)

XIENCE PRIME SV Everolimus Eluting Coronary Stent

Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent

Device: XIENCE PRIME SV Everolimus Eluting Coronary Stent

Interventions

XIENCE PRIME SV Everolimus Eluting Coronary Stent DEVICE

Patients receiving XIENCE PRIME SV Everolimus Eluting Stent

XIENCE PRIME SV Everolimus Eluting Coronary Stent

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General patient population with ischemic heart disease in Japan who are eligible for treatment with XIENCE PRIME SV Everolimus Eluting Stent will be included in the study.

* Patient informed consent is required for registration of this PMS. In cases where patient informed consent (or providing some type of information) is required for PMS per the participating site policy, the Sponsor will cooperate as needed. * If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS. * Patients who are treated (stent delivery system inserted into the body) by XIENCE PRIME SV will be registered (including provisional stenting for side branch treatment but excluding bail-out only use). * The observations will be compiled on a per-patient basis even if multiple stents are implanted during the index procedure. * A patient whose side-branch is treated by XIENCE PRIME SV can be registered. In such a case, main vessel should be treated by XIENCE PRIME. * A patient who are treated by other drug eluting stent (DES) for planned stent and XIENCE PRIME SV for bail-out purpose cannot be registered. * Additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events. * A patient who is treated, but failed to be implanted by XIENCE PRIME SV and finally treated by other devices only (No XIENCE PRIME SV are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the PRIME stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE PRIME SV stent is not required. * A patient may have another lesion(s) that may be treated by larger diameter stent(s). In such a case, treatment by XIENCE PRIME is preferable. Lesion(s) treated by other than XIENCE PRIME is not considered as the target lesion.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (33)

Kimitsu Chuo Hospital

Chiba, 292-8535, Japan

Location

Kokura Memorial Hospital

Fukuoka, 802-8555, Japan

Location

Fukuoka Wajiro Hospital

Fukuoka, 811-0213, Japan

Location

Hoshi general hospital

Fukushima, 963-8501, Japan

Location

Tsuchiya General Hospital

Hiroshima, 730-0811, Japan

Location

Hyogo Prefectural Amagasaki Hospital

Hyōgo, 660-0828, Japan

Location

Tsukuba Medical Center Hospital

Ibaraki, 305-8558, Japan

Location

Ishikawa Prefectual Central Hospital

Ishikawa, 920-8530, Japan

Location

Shonan Kamakura General Hospital

Kanagawa, 247-8533, Japan

Location

Tokai University Hospital

Kanagawa, 259-1193, Japan

Location

Kumamoto Chuo Hospital

Kumamoto, 862-0965, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Miyazaki City-Gun Ishikai Hospital

Miyazaki, 880-0834, Japan

Location

Kansai Rosai Hospital

Nagoya, 466-8650, Japan

Location

Nagoya Daini Red Cross Hospital

Nagoya, 660-8511, Japan

Location

Heart disease center Sakakibara hospital

Okayama, 700-0804, Japan

Location

Kurashiki Central Hospital

Okayama, 710-8602, Japan

Location

Sakurabashi Watanabe Hospital

Osaka, 530-0001, Japan

Location

Osaka police hospital

Osaka, 543-0035, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

Tokorozawa Heart Center

Saitama, 359-1142, Japan

Location

Tokeidai memorial hospital

Sapporo, 060-0031, Japan

Location

JCHO Hokkaido Hospital

Sapporo, 062-8618, Japan

Location

Hokkaido Ohno hospital

Sapporo, 063-0034, Japan

Location

Sendai Kousei Hospital

Sendai, 980-0873, Japan

Location

Okamura memorial hospital

Shizuoka, 411-0904, Japan

Location

Tokushima Red Cross Hospital

Tokushima, 773-8502, Japan

Location

Mitsui Memorial Hospital

Tokyo, 101-8643, Japan

Location

Toranomon hospital

Tokyo, 105-8470, Japan

Location

Tokyo Women's Medical University Hospital

Tokyo, 162-8666, Japan

Location

Teikyo University Hospoital

Tokyo, 173-8606, Japan

Location

Showa University Fujigaoka hospital

Yokohama, 227-8501, Japan

Location

Saiseikai Yokohama City Tobu Hospital

Yokohama, 230-8765, Japan

Location

MeSH Terms

Conditions

Myocardial Ischemia; Angina Pectoris; Coronary Artery Disease; Coronary Occlusion

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kusano Hajime
• Organization: Abbott Vascular

hajime.kusano@av.abbott.com

408-645-1626

Study Officials

• Ken Kozuma, MD

  Teikyo University Hospital, Tokyo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: July 17, 2015
• First Posted: August 3, 2015
• Study Start: May 13, 2013
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 4, 2024
• Results First Posted: July 22, 2019

Record last verified: 2021-04

Locations

JP (33)