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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110013 S005/ PAS001 |
| Date Original Protocol Accepted |
02/22/2013
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| Date Current Protocol Accepted |
10/16/2014
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| Study Name |
Resolute Integrity PAS Newly Enrolled
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| Device Name |
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 |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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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 |
This is a sub-study of the ongoing Resolute Integrity PAS, ordered for P110013, which is a prospective, multi-center, non- randomized, single-arm, open-label study.
To assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm in two groups of patients, specifically those patients receiving stents ¡Ü 30 mm in length, referred to as the Primary Enrollment Group (PEG) and those patients who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Sub-study (XL Sub-study).
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| Study Population |
Patients who met the inclusion/exclusion criteria for the
RESOLUTE INTEGRITY US (RI-US) - XL, evaluating the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries (Overall Study and Sub-study). The subjects enrolled with the 34mm or 38mm length stents will comprise the ¡°Extended Length Sub-study (XL) - New Enrollment Cohort¡±.
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| Sample Size |
The observed event rate for the primary endpoints is assumed to
be 3.5% so a sample size of 50 subjects will provide a 95% confidence interval [0.3%, 13.0%]. It is expected that the lost to follow-up rate at 12 months is less than 10%; however, a total of
56 patients will be conservatively enrolled in this trial to ensure that at least 50 patients will be evaluable at 12 months. Centers are allowed to enroll a maximum of sixteen (16) XL Sub-study patients per center or until study enrollment has been completed, whichever comes first.
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| Key Study Endpoints |
Primary Endpoint
The primary endpoint for all patients enrolled in this study (overall and sub-study) is the composite rate of cardiac death and target vessel myocardial infarction (MI) at 12 months
Secondary Endpoints
Composite endpoints:
Major Adverse Cardiac Events (MACE)
Target Lesion Failure (TLF)
Target Vessel Failure (TVF)
Cardiac Death and Target Vessel 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
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| Follow-up Visits and Length of Follow-up |
The length of follow-up is 5 years.
Frequency of Follow-up Assessments: 30 days, 6 months, 24 months and annually at 3, 4, and 5 years 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 24 months. The total time for the duration from first-subject enrolled to last-subject follow-up complete is approximately 7 years.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
56 subjects
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| Actual Number of Sites Enrolled |
14 sites
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| Patient Follow-up Rate |
96.3% (54/56) at 3-years
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| Final Safety Findings |
The primary endpoint of the Resolute Integrity US Extended Length (XL) Sub-Study was the composite rate of cardiac death and target vessel myocardial infarction (TVMI) at 12-months. The primary endpoint was observed in 7.4% (4/54, 95% CI:2.1%, 17.9%) of the population. The key secondary endpoints based on the ITT population through three (3) years are as follows:
MACE (Death, Myocardial Infarction, emergent coronary bypass surgery, or repeat TLR): 17.9% (10/56)
Target Lesion Failure (Cardiac Death, TVMI, Clinically Driven TLR): 10.7% (6/56)
Target Vessel Failure (Cardiac Death, TVMI, Clinically Driven TVR): 12.5% (7/56)
All Death: 3.6% (2/56)
TVMI: 5.4% (3/56)
Clinically Driven Target Lesion Revascularization: 5.4% (3/56)
Clinically Driven Target Vessel Revascularization: 7.1% (4/56)
Stent Thrombosis (ARC Definite/Probable): 2.0% (1/51)
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| Final Effect Findings |
Lesion Success, defined as the attainment of <50% residual stenosis of the target lesion using any percutaneous method, was obtained in 100.0% (67/67) of lesions. Device Success, defined as the attainment of <50% residual stenosis of the target lesion using only the assigned device, was achieved in 97.0% (65/67) of lesions. Procedural Success, defined as <50% residual stenosis and no in-hospital MACE, was achieved in 98.2% (55/56) subjects.
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| Study Strengths & Weaknesses |
Strengthes: The RESOLUTE INTEGRITY US Extended Length (XL) Sub-Study was a prospective, open-label, multicenter study. The study achieved a follow-up rate greater than 90% at 3 years. An independent clinical event committee performed adjudication of the safety endpoints including all cases of death, Q-wave myocardial infarction (QMI), non-Q-wave MI (NQMI), stent thrombosis, target lesion revascularization and target vessel revascularization.
Weakness: The sub-study is limited by the small sample size such that any further subgroup analysis can, at best, be considered exploratory.
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| Recommendations for Labeling Changes |
The sponsor will be requested to add the complete 36-month follow-up data to the labeling.
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