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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P170030 / PAS001 |
| Date Original Protocol Accepted |
11/12/2019
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| Date Current Protocol Accepted |
10/30/2020
|
| Study Name |
Bioflow-VII New Enrollment PAS
|
| Device Name |
ORSIRO Sirolimus 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 |
Objective Performance Criterion
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| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The BIOFLOW-VII study is a prospective, multi-center, single-arm study to confirm that the clinical performance of the Orsiro stent in a realworld
setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V IDE pivotal trial. Subjects who undergo percutaneous
coronary intervention (PCI) with a placed Orsiro stent within the prior 24 hours will be screened per the protocol inclusion and exclusion criteria
to achieve the desired evaluable subject counts (N=500) for the primary endpoint. The study will enroll subjects at up to 50 sites in the US. The
primary endpoint will evaluate the rate of target lesion failure (TLF) at 1 year post-index procedure. TLF is defined as a composite of cardiac
death, target vessel myocardial infarction (MI) or clinically-driven target lesion revascularization (TLR).
Subjects may have received treatment of up to three target lesions in up to two separate target vessels (e.g., two target lesions in one vessel and
one target lesion in a separate vessel). The target lesion(s) must have been de novo or restenotic (PTCA only) atherosclerotic lesion(s) of less than or equal to 36 mm in length in native coronary artery(ies), with a reference vessel diameter of 2.25–4.0 mm. All lesions treated during a single index
procedure must meet target lesion criteria.
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
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| Sample Size |
A total of 556 subjects will be enrolled to achieve 500 evaluable subjects at 1 year. Subjects will be enrolled at up to 50 clinical sites. It is estimated that no more than 20% of the projected total subjects (approximately 111 subjects) will be enrolled at single site.
Sample Size Assumption are as follows:
Performance goal: 9.0%
Target Orsiro TLF rate: 4.0%
Statistical power: 80%
Significance level: 1-sided 0.025
Evaluable sample size – 201 subjects (unadjusted).
Per FDA recommendation- 500 (adjusted)
Adjusted for 10% attrition - 556
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| Key Study Endpoints |
Primary Endpoints
The primary endpoint will evaluate the rate of TLF at 1 year post-index procedure. TLF is defined as a composite of cardiac death, target vessel myocardial infarction (MI) or clinically-driven target lesion revascularization (TLF).
Secondary Endpoint:
Secondary endpoints measured in-hospital and at 6 months, 12 months, 2 years, and 3 years after the index procedure include:
TLR rate
TLF rate (primary endpoint at 12 months)
Target vessel revascularization (TVR) rate
Target vessel failure (TVF) rate
MI (Q-wave and non–Q-wave) rate
Cardiac death rate
Non-cardiac death rate
All death rate
Cardiac death or MI rate
All death or MI rate
All death/MI/TVR rate
Stent thrombosis rates (by Academic Research Consortium [ARC] definitions)
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Interim Results |
Safety Results
Death at 3-years (1080 days) was 3.54% (17/480)
Any vessel MI was 3.43% (16/466)
Any stent thrombosis was 0.9% (5/556)
Effectiveness Results
TLF at 1 year was 1.69% (9/531)
TLF at 2 years was 4.45% (23/517)
TLF at 3 years was 5.46% (26/476)
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| Actual Number of Patients Enrolled |
556
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| Actual Number of Sites Enrolled |
31
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| Patient Follow-up Rate |
476 subjects completed 36 months of follow-up with 15 visits missed and 12 subjects pending a 36 month assessment. As of 36 months, 5 subjects have died, 3 withdrew consent, 2 exited for other reasons, and 16 subjects were otherwise lost to follow-up.
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