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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110013 / PAS002 |
| Date Original Protocol Accepted |
02/17/2012
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| Date Current Protocol Accepted |
02/17/2012
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| Study Name |
Cont Followup of Premarket and OUS Cohort
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| Device Name |
RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
No Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
These analyses will utilize the pooled data from the Global RESOLUTE Clinical Trial Program on-label usage patients (RESOLUTE All Comers (R-AC) and RESOLUTE International (R-Int), RESOLUTE initial feasibility trial (R-FIM), the pre-approval trial for Japan, RESOLUTE Japan (R-J), and the RESOLUTE US (R-US)).
Objectives:
1) Demonstrate the safety in terms of stent thrombosis (ST) when the drug-eluting stent is used in accordance with the labeled indications from 12-24, 24-36, 36-48, and 48-60 months post implant. (36-60 months excludes R-Int)
2) Demonstrate the safety in terms of cardiac death (CD) and target vessel myocardial infarction (TVMI) when the drug-eluting stent is used in accordance with the labeled indications.
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| Study Population |
The study population consists of four studies (R-FIM, R-AC, R-US, and R-J) with a five-year follow-up and one study with a three year follow-up (R-Int).
The Global RESOLUTE Clinical Trial Program has currently amassed a dataset with a combined total of 5,130 subjects with follow-up at or greater than one year. This dataset consists of 2,349 Subjects considered to be ¿off-label¿ and 2,781 ¿on-label¿ subjects (Table 1).
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| Sample Size |
Within the on-label subjects, a sample size of 1,312 will have 80% power to demonstrate the rate of ARC definite probable ST to be significantly less than 1% year-to-year. The Resolute program will have 2,781 on-label subjects scheduled for three years of follow-up and 2,017 on-label subjects scheduled for four and five years of follow up. Therefore, the Pooled Resolute program will have a large enough sample size with or without the RESOLUTE International Registry subjects.
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| Key Study Endpoints |
Primary Endpoint
ARC definite or probable ST rates from 12-24, 24-36, 36-48 and 48-60 months.
CD/TVMI annual rates up to 5 years post procedure.
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| Follow-up Visits and Length of Follow-up |
Data collection will be annually up to 5 years of follow-up, except for R-Int (36 months)
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
2,017 on-label subjects
764 complex subjects
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| Actual Number of Sites Enrolled |
RESOLUTE All Comers (R-AC): 17 sites
RESOLUTE initial feasibility trial (R-FIM): 12 sites
RESOLUTE Japan (R-J): 14 sites
RESOLUTE United States (R-US): 116 sites
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| Patient Follow-up Rate |
On-label: 96% (1937/2017) Complex: 98% (751/764)
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| Final Safety Findings |
Objective 1:
The annual rate of Academic Research Consortium (ARC)-defined definite and probable stent thrombosis (ST) at 5 years for on-label patients pooled from four studies (R-FIM, R-AC, R-US, and R-J) part of the Global RESOLUTE Clinical Trial Program was 0.02% (3/1937, upper 95% CI: 0.4%).
The 5-year cumulative rate of ARC- definite/probable ST through five years was 0.8% (15/1937) for on- label subjects and 2.5% (19/751) for complex subjects.
Objective 2:
The 5-year cumulative rate of cardiac death or myocardial infarction for on-label and complex subjects pooled from four studies (R-FIM, R-AC, R-US, and R-J) part of the Global RESOLUTE Clinical Trial Program was 7.5% (145/1937) and 11.9% (89/751), respectively.
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| Final Effect Findings |
Procedural success: 97.9% (1961/2003)
Device success: 98.3% (2251/2289)
Lesion success: 99.9% (2283/2285)
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| Study Strengths & Weaknesses |
This study provides longer term (5 years) safety and effectiveness results of the Resolute Zotarolimus- Eluting Coronary Stent System. This study followed up the premarket cohorts through five years post- procedure. The study had a very low rate of attrition, thus minimizing selection bias. It demonstrated that the Resolute Zotarolimus-Eluting Coronary Stent System had a rate of ARC-definite/probable ST to be significantly less than 1% year-to-year. Although three of the four trials were conducted outside the US, 70% of the on-label subjects (1402/2017) were enrolled in the US. There were no complex subjects enrolled in US sites.
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| Recommendations for Labeling Changes |
A labeling change is recommended to add a summary of the post-approval study results including study strengths and limitations. The updated label will reflect the long-term (5-years) postmarket performance of the device.
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