N/A
N=536
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
Angina · Coronary Occlusion · Coronary Artery Disease · Coronary Artery Stenosis · Myocardial Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT01721096 ↗Enrolled (actual)
536
Serious AEs
41.2%
Results posted
Jul 2016
Primary outcome: Primary: Number of Participants With Acute Stent Thrombosis (ST) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- XIENCE PRIME - Long Length (LL) (Device); XIENCE PRIME - Core Size (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Stent Thrombosis (ST) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Subacute Stent Thrombosis (ST) |
3; 0; 0; 0; 3; 0 | — |
| PRIMARY Number of Participants With Late Stent Thrombosis (ST) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Total Number of Participants With Overall Stent Thrombosis |
3; 0 | — |
| SECONDARY Success Rate: Percentage of Participants With Implant Success Rate by Device |
99.8; 99.6 | — |
| SECONDARY Success Rate: Percentage of Participants With Procedural Success by Lesion |
100; 100 | — |
| SECONDARY Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base) |
100; 99.5 | — |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) |
26; 7 | — |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) |
26; 7 | — |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) |
26; 7 | — |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) |
26; 7 | — |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) |
26; 7 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
106; 55 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
106; 55 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
106; 55 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
106; 55 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
106; 55 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
37; 15 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
37; 15 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
37; 15 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) |
37; 15 | — |
| SECONDARY Number of Participants With Target Vessel Failure(TVF) |
43; 17 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) |
30; 9 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) |
30; 9 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) |
30; 9 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) |
30; 9 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) |
30; 9 | — |
| SECONDARY Number of Participants With Death or Myocardial Infarction (MI) |
29; 15 | — |
| SECONDARY Number of Participants With Death or Myocardial Infarction (MI) |
29; 15 | — |
| SECONDARY Number of Participants With Death or Myocardial Infarction (MI) |
29; 15 | — |
| SECONDARY Number of Participants With Death or Myocardial Infarction (MI) |
29; 15 | — |
| SECONDARY Number of Participants With Death or Myocardial Infarction (MI) |
29; 15 | — |
| SECONDARY Number of Participants With Cardiac Death or Myocardial Infarction (MI) |
11; 3 | — |
| SECONDARY Number of Participants With Cardiac Death or Myocardial Infarction (MI) |
11; 3 | — |
| SECONDARY Number of Participants With Cardiac Death or Myocardial Infarction (MI) |
11; 3 | — |
| SECONDARY Number of Participants With Cardiac Death or Myocardial Infarction (MI) |
11; 3 | — |
| SECONDARY Number of Participants With Cardiac Death or Myocardial Infarction (MI) |
11; 3 | — |
| SECONDARY Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) |
7; 1 | — |
| SECONDARY Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) |
7; 1 | — |
| SECONDARY Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) |
7; 1 | — |
| SECONDARY Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) |
7; 1 | — |
| SECONDARY Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) |
7; 1 | — |
| SECONDARY Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) |
19; 13 | — |
| SECONDARY Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) |
5; 6 | — |
| SECONDARY Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) |
19; 13 | — |
| SECONDARY Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) |
19; 13 | — |
| SECONDARY Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) |
19; 13 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) |
6; 2 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) |
6; 2 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) |
6; 2 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) |
6; 2 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) |
6; 2 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
26; 8 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
26; 8 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
26; 8 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
26; 8 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization(TLR) |
29; 9 | — |
| SECONDARY Number of Participants With Non-Target Lesion Revascularization (Non-TLR) |
20; 17 | — |
| SECONDARY Number of Participants With Non-Target Lesion Revascularization (Non-TLR) |
20; 17 | — |
| SECONDARY Number of Participants With Non-Target Lesion Revascularization (Non-TLR) |
20; 17 | — |
| SECONDARY Number of Participants With Non-Target Lesion Revascularization (Non-TLR) |
20; 17 | — |
| SECONDARY Number of Participants With Non-Target Lesion Revascularization (Non-TLR) |
20; 17 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) |
46; 25 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR)) |
28; 13 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) |
46; 25 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) |
46; 25 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) |
46; 25 | — |
| SECONDARY Number of Participants With Non-Target Vessel Revascularization (Non-TVR) |
57; 25 | — |
| SECONDARY Number of Participants With Non-Target Vessel Revascularization (Non-TVR) |
57; 25 | — |
| SECONDARY Number of Participants With Non-Target Vessel Revascularization (Non-TVR) |
57; 25 | — |
| SECONDARY Number of Participants With Non-Target Vessel Revascularization (Non-TVR) |
57; 25 | — |
| SECONDARY Number of Participants With Non-Target Vessel Revascularization (Non-TVR) |
57; 25 | — |
| SECONDARY Number of Participants With All Revascularization |
87; 45 | — |
| SECONDARY Number of Participants With All Revascularization |
87; 45 | — |
| SECONDARY Number of Participants With All Revascularization |
87; 45 | — |
| SECONDARY Number of Participants With All Revascularization |
87; 45 | — |
| SECONDARY Number of Participants With All Revascularization |
87; 45 | — |
| SECONDARY Number of Participants Experienced Bleeding |
1; 4 | — |
| SECONDARY Number of Participants Experienced Bleeding |
1; 4 | — |
| SECONDARY Number of Participants Experienced Bleeding |
1; 4 | — |
| SECONDARY Number of Participants Experienced Bleeding |
1; 4 | — |
| SECONDARY Number of Participants Experienced Bleeding |
1; 4 | — |
| SECONDARY Percent Diameter Stenosis (%DS) |
29.17; 25.12 | — |
| SECONDARY Percent Diameter Stenosis (%DS) |
29.17; 25.12 | — |
| SECONDARY Percent Diameter Stenosis (%DS) |
29.17; 25.12 | — |
| SECONDARY Acute Gain: In-stent, In-segment |
1.81; 1.81; 1.42; 1.40 | — |
| SECONDARY Net Gain: In-stent, In-segment |
1.53; 1.68; 1.31; 1.34 | — |
| SECONDARY Late Loss(LL): In-stent, In-segment, Proximal, and Distal |
0.27; 0.15; 0.13; 0.08; -0.04; 0.03 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01721096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.