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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P220021 / PAS001 |
| Date Original Protocol Accepted |
06/07/2023
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| Date Current Protocol Accepted |
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| Study Name |
DETOUR2 Continued Follow-up Study
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| Device Name |
DETOUR System
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| Clinical Trial Number(s) |
NCT03119233
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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 |
DETOUR 2
To evaluate the long-term safety and effectiveness of the DETOUR System. The study is continued follow-up of the pivotal DETOUR 2 trial cohort (G170083). The premarket was a prospective, single arm, multicenter study that treated 220 subjects at 36 investigation sites.
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| Study Population |
DETOUR2
All remaining subjects treated with the DETOUR System in the DETOUR 2 trial active at the time of 12 months evaluation. There is no comparator group.
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| Sample Size |
DETOUR 2 -All 197 subjects remaining in the DETOUR 2 trial study at 12 months will be enrolled.
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| Key Study Endpoints |
DETOUR 2
Endpoints to be assessed at 24 and 36 months include
Major Adverse Events (MAE)
Symptomatic Deep Vein Thrombosis (DVT) on ipsilateral limb
Pulmonary embolism
Stent graft separation and migration identified via ultrasound imaging
Clinical Success defined as limb ischemia improvement as assessed by Rutherford Clinical Classification (improvement in scale by =1)
Limb ischemia by Rutherford Clinical - Classification
Primary Patency
Primary assisted patency
Secondary patency
Target Vessel Revascularization
Ankle-Brachial Index (ABI) or Toe Brachial Index (TBI) of both the index limb and contralateral limb
Major index limb amputations
Venous Clinical Severity Score and Villalta Scale
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| Follow-up Visits and Length of Follow-up |
DETOUR 2 - 3 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
DETOUR2: 220 subjects (202 enrolled subjects plus18 roll-in subjects)
Continued Access: 11 subjects were enrolled with intention to treat at 5 sites, and 10 subjects were treated with the device in the U.S.
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| Actual Number of Sites Enrolled |
DETOUR2: 32 US and 4 OUS
Continued Access: 8
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| Patient Follow-up Rate |
DETOUR2: Enrolled Subjects All Subjects: 96.6% (169/175) at 24 months and 98.7% (153/155) at 36 months. Roll-in Subjects: 100% (13/13) at 24 months and 100% (11/11) at 36 months.
Continued Access:
30 days - 100% (10) 6 months -100% (9) 12 months - 100% (8/8) 24- months - 100% (6/6)
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| Final Safety Findings |
DETOUR2: Major Adverse Events (MAE): MAE were defined as any of the following: all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major amputation of the treated limb, symptomatic deep vein thrombosis, pulmonary embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery.
Through 24 months the Kaplan Meier (KM) estimate for MAE was 33.1%, with 24.8% of subjects experiencing clinically driven target lesion revascularization (CD-TLR). At 36 months the KM estimate for MAE was 42.3% with 32.7% of subjects experiencing CD-TLR. The KM estimate for death was 4.8% at 24-months, and 8.9% at 36-months. In all subjects, the amputation rate (within the treated limb) remained at 2.1% from 12 through 36 months. In roll-in subjects, through 24 months the KM estimate for MAE was 46.7%, with 42.9% of subjects experiencing CD-TLR. Through 36 months the KM estimate for MAE was 46.7% and 42.9% of subjects experienced CD-TLR. No stent fractures were reported by the Core Lab on X-ray (evaluated only at the 12-month follow-up visit). One (1) stent graft separation and one (1) stent migration >1cm were observed (0.6% each; 1/180 and 1/180 respectively) at 12-month follow-up. There were no fractures, stent graft separations or migrations at 24 or 36 months. There were no fractures, stent graft separations or migrations in the roll-in population at any timepoint.
Continued Access:
The MAE rate was 9.1% (1/11) through 30-days, with symptomatic deep vein thrombosis as the only occurring MAE component. The MAE rate through 12-months was 45.5% (5/11). At 24-months, the cumulative MAE rate was 87.5% (7/8). All-Cause Mortality was the most common MAE component, occurring in 50.0% (4/8) of subjects. Clinically driven TLR rate at 24 months was 37.5 % (3/8). Serious Adverse Events (SAEs) Through 12-months, SAEs were adjudicated by the clinical event committee in 54.5% (6/11) subjects, with subjects experiencing one or more SAEs. The most commonly reported SAE was Vascular Disorders (27.3%, 3/11). From 12 through 24-months, there was 37.5% (3/8) subjects with SAEs adjudicated by the CEC.
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| Final Effect Findings |
DETOUR2: At 24 months, the KM estimate for primary patency was 59.5% and at 36 months the KM patency rate was 49.8%. At 24 months and 36 months the KM estimate for primary patency in the roll-in subjects was 57.1% and 42.9% respectively. At 24 months, secondary patency rate was 85.3% and 84.6% for enrolled cohort and roll-in subjects respectively. At 36 months, secondary patency was 76.2% for enrolled group and remained at 84.6% for the roll-in group. Rutherford Assessment: A negative value for change from baselines indicates an improvement in Rutherford class. At 24- and 36-months post-procedure, the Rutherford class improved by an average score of - 2.7. ABI (Ankle Brachial Index): At 24- and 36-month post-procedure, the mean change in ABI from baseline in the target limb was 0.37 and 0.35 respectively. Villalta Scale: A negative change from baseline indicates improvement in the parameter assessed. At 24- and 36-months post-procedure, the overall Villalta score showed an improvement from baseline with -0.8 and -0.5 respectively. Target Vessel Revascularization (TVR): At 24 months post-procedure, the KM estimate for TVR was 32.9%, and at 36-months post-procedure the KM estimate was 41.4%.
Venous Clinical Severity Score (VCSS): A negative change from baseline indicates improvement in the parameter assessed. At 24-and 36-months post-procedure, the approximate overall change in VCSS from baseline was 0.3 and 0.6 respectively.
Continued Access:
Rutherford Assessment As of the final data cut at 24-months post-procedure, the most common Rutherford score was 0 (66.7%).
ABI (Ankle Brachial Index) At 24-months post-procedure, the mean change in ABI from baseline was 0.50. Villalta Scale As of the final data cut, at 24-months post-procedure, showed follow-up score mean of 0.2 +/- 0.4 (6) and median of 0.0 (0.0, 1.0). Venous Clinical Severity Score (VCSS) At 24-months post-procedure, the approximate overall change in VCSS from baseline was 0.0 +/- 0.0 (6). Stent Graft Patency At 12- and 24-months post-procedure, stent graft patency rate was 85.7% (6/7) and 83.3% (5/6) respectively. Secondary Patency Secondary patency rate was 88.9% at 12 and 24-months by Kaplan-Meier method.
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| Study Strengths & Weaknesses |
DETOUR2
Strengths This was a prospective multicenter study that compared safety and effectiveness of the DETOUR System to a performance goal (PG). Both primary safety and effectiveness endpoints were met (for primary safety the lower bound of the exact sided 97.5% confidence interval for MAE was 88.5% versus PG of 84%; for primary effectiveness endpoint or patency, the lower bound was 60.9% versus 60.4% PG. Weaknesses Subjects were non-randomized. Approximately 75.7% (153/202) enrolled subjects and 61.1% (11/18) roll-in subjects completed.
Continued Access:
This study had a very small sample size. No subject was lost to follow-up. The main reason for premature discontinuation among subjects was death
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| Recommendations for Labeling Changes |
DETOUR2: Labeling change is recommended with the final long-term follow-up results.
Continued Access: Labeling updates are under review.
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