|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110013 / PAS001 |
| Date Original Protocol Accepted |
02/17/2012
|
| Date Current Protocol Accepted |
02/17/2012
|
| Study Name |
Resolute Integrity
|
| Device Name |
RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
|
| Clinical Trial Number(s) |
NCT00248079 NCT00617084 NCT00726453 NCT00752128 NCT00927940 NCT01150500
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, multi-center, non- randomized, single-arm, open-label study.
|
| Study Population |
Patients with de novo lesions in native coronary arteries that meet the eligibility criteria and sign the informed consent form will participate in this study.
|
| Sample Size |
The observed event rate for the primary endpoints is assumed to be 2% at 12 months so a sample size of 200 subjects will provide a 95% confidence interval [0.5%, 5%]. It is expected that the lost to follow-up rate at 12 months is less than 10%; however, a total of 230 patients will be conservatively enrolled in this trial to ensure that at least 200 patients will be evaluable at 12 months.
Centers (n≈30) are allowed to enroll a maximum of 40 subjects per center or until study enrollment has been completed, whichever comes first.
|
| Key Study Endpoints |
Primary Endpoint
The primary endpoint for all patients enrolled in this study is the composite rate of cardiac death and TV MI at 12 months
Secondary Endpoints
Composite endpoints (hospital discharge, 30 days, 6 months, 12 months, and 24 months post-procedure):
¿ Major Adverse Cardiac Events (MACE)
¿ Target Lesion Failure (TLF)
¿ Target Vessel Failure (TVF)
¿ Cardiac Death and TV MI
Clinical endpoints:
¿ Death
¿ Myocardial Infarction
¿ Target Lesion Revascularization (TLR)
¿ Target Vessel Revascularization (TVR)
¿ Stent Thrombosis
¿ Stroke
¿ Bleeding complications in general
¿ Dual antiplatelet therapy (DAPT) compliance
In addition, the following will be assessed:
¿ Procedural success
¿ Device success
¿ Lesion success
|
| Follow-up Visits and Length of Follow-up |
The length of follow-up is 2 years.
Frequency of Follow-up Assessments: 30 days, 6 months, 12 months, and 24 months post-procedure.
The patient must return to the site where the procedure was performed for a clinic visit and 12-lead ECG at 12 months. The expected length of time for enrollment is approximately 12 months. The study will be conducted for a minimum of two (2) years from enrollment of the final subject.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
230 subjects
|
| Actual Number of Sites Enrolled |
Thirty sites enrolled in the study; however, one site did not enroll any study subjects and was subsequently closed.
|
| Patient Follow-up Rate |
94.8% (218/230)
|
| Final Safety Findings |
Primary endpoint: Cardiac death (CD) and target vessel myocardial infarction (TVMI) at 12 months: 3.5% (8/226, 95% CI: 1.5%-6.9%). It was expected that the composite rate of CD/TVMI will be consistent with the rate observed in the Resolute-US pre-approval trial (2% [95% CI: 0.5% - 5%]). The rate in this PAS does not seem to be much different. However, this PAS was designed to provide certain precision around the primary endpoint rate and not to test for differences in the studies¿ rates.
Secondary endpoints at 24 months:
Cardiac Death and Target Vessel Myocardial Infarction: 5.9% (13/219)
Target Lesion: 9.1% 9.1% (20/219) Target Vessel Failure: 12. 3% (27/219)
Major Adverse Cardiac Events: 11.0% (24/219) Death: 2. 7% (6/219)
Cardiac Death: 1.9% (4/209)
Target Vessel Myocardial Infarction: 4.1% (9/219)
Clinically Driven Target Lesion Revascularization: 5.0% (11/219) Clinically Driven Target Vessel Revascularization: 8. 2% (18/219)
Academic Research Consortium- definite/probable stent thrombosis: 1.9% (4/209) Stroke: 0.9% (2/219)
Bleeding Complications in General: 12. 8% (28/219) Dual antiplatelet therapy compliance: 65.1% (136/209)
|
| Final Effect Findings |
Lesion Success1: 99.2% (243/245)
Device Success2: 99.2% (243/245)
Procedure Success3: 97.4% (221/227)
1 The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method.
2 The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
7 The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.
|
| Study Strengths & Weaknesses |
This study provides longer term (2 years) safety and effectiveness results of the Resolute Zotarolimus- Eluting Coronary Stent System. This post-approval study was conducted in the United States and had a very low lost to follow-up rate. This study confirmed the safety and effectiveness results of the premarket data on the Resolute Zotarolimus-Eluting Coronary Stent System.
|
| 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 (2-years) postmarket performance of the device.
|
