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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P150039 / PAS003 |
| Date Original Protocol Accepted |
07/13/2017
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| Date Current Protocol Accepted |
10/04/2020
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| Study Name |
TRYTON Side Branch New Enrollment Study
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| Device Name |
TRYTON SIDE BRANCH STENT
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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 |
Objective Performance Criterion
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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 |
To assure the continued safety and effectiveness of the Tryton Side Branch Stent™ with main branch approved DES in the treatment of de novo native coronary artery bifurcation lesions with side branch diameter ranging from greater than or equal to 2.5 mm to less than or equal to 3.5 mm and main branch diameter ranging from greater than or equal to 2.5 mm to less than or equal to 4.0 mm.
-A prospective, single arm, open label multicenter registry of newly enrolled patients.
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| Study Population |
U.S. patients with symptomatic, ischemic heart disease due to a stenotic bifurcation lesion located in a de novo native coronary artery, with side branch diameter ranging from greater than or equal to 2.5 mm to less than or equal to 3.5 mm and main branch diameter ranging from greater than or equal to 2.5 mm to less than or equal to 4.0 mm.
Patients must meet all inclusion and exclusion criteria per labeling.
The comparator is performance goal (TVF rate of 18.9% at 1 year) derived from the Tryton IDE Tryton intended cohort, greater than or equal to 2.25 mm subset.
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| Sample Size |
A maximum of 335 subjects will be enrolled at minimum of 60 sites and a maximum of 85 sites in the US.
Sample size assumptions are as follows:
Primary endpoint: Incidence rate of TVF (cardiac death, myocardial infarction, target vessel re- vascularization) within 1 year of index procedure.
1-sided test at 0.5 significance level
Power of 85%
Expected TVF rate: 13.4%
Sampling variability adjustment: 5.5%
Reference TVF rate: 18.9% (13.4% + 5.5%)
Expected missing data/attrition: 10%
A continuity-corrected normal approximation (z-test) to the binomial distribution was used in the determination of the sample size.
A sub study of the first 150 patients treated by inexperienced operators will be enrolled and evaluated by the Angiographic Core Laboratory to assess side branch reference vessel diameter.
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| Key Study Endpoints |
Primary Endpoint
• TVF rate at 1 year post index procedure.
TVF is a composite rate of cardiac death, target vessel myocardial infarction (Q Wave and Non-Q wave MI), and clinically driven TVR.
Secondary Endpoints
1. Device success, defined as attainment of <30% residual stenosis within the side branch without device malfunction
2. Lesion success, defined as attainment of <30% residual stenosis using any percutaneous method
3. Procedure success, defined as lesion success without malfunction or in-hospital MACE, (cardiac death, Q wave or non-Q wave MI, or repeat revascularization of the target lesion during the hospital stay),
and the following secondary endpoints which will be evaluated at 30 days, and annually to 3 years.
4. All-cause and cardiac mortality,
5. Myocardial infarction (MI), Q wave and non-Q wave
6. Clinically driven target lesion revascularization (CD- TLR)
7. Clinically driven target vessel revascularization (CD- TVR)
8. Stent thrombosis, using ARC definition of definite and probable
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| Follow-up Visits and Length of Follow-up |
3 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
30
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| Actual Number of Sites Enrolled |
9
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| Patient Follow-up Rate |
100% (30/30) at 1 year (primary endpoint); 37% (11/30) at 2 years when study terminated
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| Final Safety Findings |
CEC-adjudicated event rates through 1 year are as follows:
Stent thrombosis (ARC definite, probable)- 0.0% (0/30)
MI (Peri-procedural after PCI) – 10.3% (3/29)
MI (Spontaneous) – 3.3% (1/30)
All-cause and cardiac death – 0.0% (0/30)
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| Final Effect Findings |
CEC-adjudicated event rates through 1 year are as follows:
Target vessel failure (primary endpoint) – 13.3% (4/30)
Clinically driven target lesion revascularization – 0.0% (0/30)
Clinically driven target vessel revascularization – 3.3% (1/30)
Device success – 96.7% (29/30)
Lesion success – 100% (30/30)
Procedure success – 90.0% (27/30)
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| Study Strengths & Weaknesses |
Due to difficulties with enrollment, only 30 of the planned 335 subjects were enrolled. Therefore, no statistical conclusions can be drawn from the results. The results reported are similar to those seen in the pivotal study and confirmatory study.
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| Recommendations for Labeling Changes |
No. The TRYTON Side Branch Stent is no longer marketed.
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