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| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P070014 S010/ PAS001 |
| Date Original Protocol Accepted |
12/23/2010
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| Date Current Protocol Accepted |
07/11/2014
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| Study Name |
CONTINUUM Long Lesion PAS
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| Device Name |
LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
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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 |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a single-arm, non-randomized, prospective, multi-center international study in subjects (>=22 years of age) with TransAtlantic Inter-Society Consensus A, B and C lesion(s) in the infra-inguinal segment (SFA and/or Popliteal arteries). Subjects will be treated with PTA followed by the LifeStent Self-Expanding Stent System (FlexStar / FlexStar XL). The primary objectives of this investigation are to provide confirmatory evidence of safety and effectiveness of the LifeStent Self-Expanding Stent System in patients with de novo and restenotic (non-stented) lesion(s) in the infra-inguinal segment (SFA and/or Popliteal arteries). A secondary objective of this investigation is to continue to evaluate the clinical utility of the LifeStent Self-Expanding Stent System.
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| Study Population |
The study population will be comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain and are candidates for PTA and stenting. A minimum number of patients with longer lesions will be enrolled.
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| Sample Size |
170 patients; 20 sites
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| Key Study Endpoints |
The primary safety endpoint is freedom from death at 12 months post-procedure. The primary effectiveness is freedom from procedural device malfunction.
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| Follow-up Visits and Length of Follow-up |
Subjects will undergo a clinical evaluation at baseline (prior to study procedure), prior to hospital discharge, 30 days post-procedure, 12, 24, and 36 months post-procedure.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
A total of 173 subjects were enrolled as follows:
113 enrolled under P070014 (Target Lesion lengths less than or equal to 160 mm),
18 enrolled under subgroup P070014/S010 (Target Lesion lengths >160 - 240 mm) and
41 enrolled under subgroup P070014/S022 (Target Lesions treated with 200 mm LifeStent SOLO).
1 subject had target lesion length of 280 mm that is not included in the subgroup categories.
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| Actual Number of Sites Enrolled |
A total of 30 sites received IRB approval and were enrolled.
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| Patient Follow-up Rate |
Follow-up rates for the combined subgroups at 30 days, and 12, 24, and 36 months was 98.8%
(163/165), 98.6% (142/144), 98.3% (115/117) and 97.7% (84/86), respectively.
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| Final Safety Findings |
Primary safety was defined as freedom from occurrence of death at 30 days and 12-months post procedure. The freedom from primary safety event rate at 30 days and 12 months post index procedure was 99.4% (95% confidence interval [CI] 95.9%, 99.9%) and 95.1% (95% CI 90.4%, 97.5%) respectively.
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| Final Effect Findings |
Primary effectiveness (Device Success) for the CONTINUUM study was defined as: freedom from device delivery failure and primary Target Lesion Patency (TLP) at 12-months post-index procedure measured by DUS. TLP was defined as the interval following the index procedure until a DUS assessment indicates that the target lesion(s) is no longer patent; that is, the treated segment has a peak systolic velocity ratio (PSVR) greater than or equal to 2.5. Primary effectiveness at 12 months by Kaplan Meier method was 72.7% (95% confidence interval [CI] 61.8 to 81.0%).
Primary target lesion patency (TLP) at 12-Months post-index procedure by Kaplan Meier analysis for CONTINUUM LifeStent group was 75.3% (95% CI: 67.4%, 81.6%) compared to RESILIENT PTA 36.7% (95% CI: 25.1%, 48.4%). The hazard ratio for CONTINNUUM LifeStent over RESILIENT PTA (ITT) was 0.123, P <0.001.
For non- inferiority comparison of the CONTINUUM Lifestent to RESILIENT LifeStent, the primary TLP at 12 months for CONTNUUM LifeStent was 81.1% versus RESILIENT LifeStent 73.2% using Cox’s regression model with regression covariates: treatment group, Rutherford Category, target lesion length, total treated segment length, age, and gender.
The difference in primary TLP at 12 months between CONTINUUM LifeStent and RESILIENT LifeStent is 0.079 (7.9%). The lower bound of the 95% CI for the difference in TLP between CONTINNUUM LifeStent and RESILIENT LifeStent of -0.006 is greater than -0.075, the non-inferiority margin, indicating that the CONTINUUM arm is not inferior to the RESILENT arm. The Z-test statistic is equal to 2.99, p-value = 0.0014.
Freedom from TLR and/or TVR at 12 months post index procedure for the CONTINUUM LifeStent group was 82.2% (95% CI 75.2%, 87.3%) compared to that of RESILIENT PTA (ITT) group 45.2% (95% CI: 33.4%, 56.3%) – (p-value <0.001).
The percentage of subjects free from stent fracture at 12- and 24-months post-index procedure was 92.4% (110/119) and 67.6% (69/102) respectively.
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| Study Strengths & Weaknesses |
Overall, approximately 74% (173/234) of required enrollment was achieved in the CONTNUUM study. The target enrollment of at least 64 subjects in each subgroup was not achieved in two subgroups. The two subgroups were: 1) Target Lesion Lengths > 160 mm and less than or equal to 240 mm, and 2) Target Lesions treated with the 200 mm LifeStent SOLO.
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| Recommendations for Labeling Changes |
Labeling change is not recommended with the post approval study results as the study was not completed.
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