Overview

This trial is active, not recruiting.

Conditions angina, coronary occlusion, coronary artery disease, coronary artery stenosis, myocardial ischemia
Treatments xience prime - long length (ll), xience prime - core length
Sponsor Abbott Vascular
Start date November 2012
End date April 2018
Trial size 500 participants
Trial identifier NCT01721096, 12-398

Summary

The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
300 patients receiving LL stent in 28, 33, or 38 mm length
xience prime - long length (ll)
Long Length
200 patients with 8, 12, 15, 18 or 23 mm stents
xience prime - core length
Core Length

Primary Outcomes

Measure
Stent thrombosis (ST)
time frame: 8 months post index procedure
Stent thrombosis (ST)
time frame: 1 year post index procedure
Stent thrombosis (ST)
time frame: 2 years post index procedure
Stent thrombosis (ST)
time frame: 3 years post index procedure
Stent thrombosis (ST)
time frame: 4 years post index procedure
Stent thrombosis (ST)
time frame: 5 years post index procedure
Adverse events (AE) caused by Anti-platelet Medications
time frame: 8 months post index procedure
Adverse events (AE) caused by Anti-platelet Medications
time frame: 1 year post index procedure
Adverse events (AE) caused by Anti-platelet Medications
time frame: 2 years post index procedure
Adverse events (AE) caused by Anti-platelet Medications
time frame: 3 years post index procedure
Adverse events (AE) caused by Anti-platelet Medications
time frame: 4 years post index procedure
Adverse events (AE) caused by Anti-platelet Medications
time frame: 5 years post index procedure

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent - Patient provides Informed Consent Form Exclusion Criteria: - 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.

Additional Information

Official title XIENCE PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan
Description The primary objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation by PMDA.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Abbott Vascular.