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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P220021 / PAS002 |
| Date Original Protocol Accepted |
08/09/2023
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| Date Current Protocol Accepted |
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| Study Name |
PTAB1 New Enrollment Registry Study
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| Device Name |
DETOUR 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 A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, single arm, registry-based study to evaluate the real-world use of the DETOUR System
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| Study Population |
Patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis > 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments.
Inclusion Criteria
Participants should be a candidate for the DETOUR System as assessed by the treating physician after review of the clinical and anatomic Indications for Use.
Exclusion Criteria
There are no exclusion criteria. All cases entered in the registry at participating centers will be included up through the targeted goals per the enrollment plan.
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| Sample Size |
Number of subjects: A maximum of 450 subjects will be enrolled with at least 200 evaluable female and 200 evaluable male subjects at the 12-month post-procedure follow up.
Assumptions for sample size estimation:
With an assumed 12% drop-out rate through 1 year, a sample size of 400 patients will provide sufficient precision in 1-year estimates, and the subgroup sample size of 200 females allows precision of the KM estimate in line with the DETOUR2 study.
Duplex Imaging Cohort
Sites that are performing (arterial and venous) duplex ultrasound assessments according to the institution’s standard practice will be asked to participate in the DUS imaging cohort.
A vascular imaging sub-study of the first 55 females and 55 males enrolled will be completed. The sample size used for imaging cohort (n=110) will provide approximately 60 patients evaluable at year 5 for imaging-driven outcomes. This is a sufficient sample size to evaluate the outcomes as they are not extremely rare (<1%).
Number of sites: 200 clinical sites.
Sites location: United States
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| Key Study Endpoints |
Primary Safety Endpoints
Freedom from a major adverse event (MAE) at 30 days post-procedure defined as any occurrence of the following events: death, clinically-driven target lesion revascularization (CD-TLR), and/or major amputation of the treated Limb.
Primary Effectiveness Endpoints
Patency as defined as Freedom from clinical driven target lesion revascularization (CD-TLR) through 1 year.
Secondary Endpoints:
1. Major Amputation of the Treated Limb
2. All-Cause Mortality
3. Major Adverse Limb Event (MALE) defined as above-ankle amputation or major reintervention including placement of a new bypass graft, interposition graft, thrombectomy, or thrombolysis
4. Symptomatic Deep Vein Thrombosis (DVT) on ipsilateral limb: Clinical symptoms (including, but are not limited to:
pain, swelling, warmth, redness, tenderness, cramps, pale/bluish decolorization of the skin of the affected extremity) and evidence of occlusive thrombus within a deep vein.
5. Incidental Venous Thrombus
6. Pulmonary embolism (PE)
7. Procedure-related myocardial infarction
8. Patency defined as flow within the stent graft without reintervention
9. Primary assisted patency defined as: revascularization of non-occlusive (<99%) stenosis within the stent graft or immediately above or below the treated arterial segment with less than 50% residual stenosis
10. Secondary patency defined as: revascularization of occlusion (100%) within the stent graft or immediately above or below the treated arterial segment with less than 50% residual stenosis
11. Amputation-free survival
12. Procedure-related infections
13. Procedure duration
14. Length of stay (from Index procedure to discharge)
15. Discharge status (from Index procedure)
Imaging Sub-study Endpoints
Imaging-driven graft patency defined as the absence of clinically driven target lesion revascularization (CD-TLR) and absence of recurrent target lesion diameter stenosis >50% by imaging (e.g., duplex ultrasound peak systolic velocity ratio peak systolic velocity ratio [PSVR] of >2.5 or as measured by invasive angiography) within the stent or immediately 1cm above or below the treated segment.
Venous thrombus within the vein containing the graft (i.e thrombus or fibrin within the vein containing the graft as observed on imaging without symptoms)
Symptomatic DVT: Clinical symptoms (including, but are not limited to: pain, swelling, warmth, redness, tenderness, cramps, pale/bluish decolorization of the skin of the affected extremity) and evidence of occlusive thrombus within a deep vein.
Occlusive DVT
Non-occlusive DVT
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| Follow-up Visits and Length of Follow-up |
1, 12, 24-, 36-, 48- and 60-months post-procedure. Follow-up assessments at 48 and 60 months may be conducted via a telephone call.
The sub-study will include Duplex imaging at 1-, 12-, 24-, and 36-months post-procedure to assess the endpoints of graft patency and venous thrombus within the vein containing the graft.
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