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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P210025 / PAS001 |
| Date Original Protocol Accepted |
06/16/2023
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| Date Current Protocol Accepted |
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| Study Name |
TRANSCEND Continued Follow-up Study
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| Device Name |
SurVeil Drug-Coated Balloon
|
| Clinical Trial Number(s) |
NCT03241459
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
To show sufficient long term safety and effectiveness of the SurVeil DCB for use in superficial femoral or popliteal arteries.
The study was designed as a global, multicenter, single blind, randomized trial.
This study is continued follow-up of premarket cohorts.
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| Study Population |
Adult patients with PAD
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| Sample Size |
N=446 (n=222 Surveil DCB; n=224 IN.PACT Admiral DCB)
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| Key Study Endpoints |
The primary safety endpoint was a composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven target vessel revascularization (TVR) through 12 months post-index procedure.
The primary effectiveness endpoint was primary patency, defined as a composite of freedom from clinically-driven TLR and binary restenosis (restenosis defined as DUS peak systolic velocity ratio [PSVR] greater than or equal to 2.4 or greater than or equal to 50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.
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| Follow-up Visits and Length of Follow-up |
5 years annually
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| Interim or Final Data Summary |
| Interim Results |
There were no events of major target limb amputation in any of the SurVeil DCB subjects and only three events of thrombosis at the target lesion (day 591, day 1352 and day 1592 post-procedure). Target vessel patency (79.4% for SurVeil DCB and 81.3% for IN.PACT Admiral DCB at 12 months; 62.6% and 63.1%, respectively, at 24 months), sustained clinical improvement (65.8% and 69.6% at 12 months; 56.7% and 59.7% at 24 months), CD-TLR (5.5% and 4.6% at 12 months; 14.5% and 11.7% at 24 months; 20.1% and 19.5% at 36 months; 25.3% and 25.8% at 48 months; 37.4% and 35.3% at 60 months), and historical MAE (8.3% and 7.7% at 12 months; 21.4% and 17.9% at 24 months; 28.3% and 28.5% at 36 months; 34.7% and 35.6% at 48 months; 49.3% and 47.0% at 60 months) are comparable, with no statistical or clinical differences shown.
Safety Results:
Safety: Freedom from all-cause mortality at all times points (KM) is 82.9% (Surveil) and 84% (IN.Pact).
Through 60 months, key adverse event rates are as follows:
- CDTLR: Surveil (37.4%); IN.PACT (35.3%)
- Major target limb amputation: Surveil (0.9%); IN.PACT (1.7%)
- Thrombosis at the target lesion: Surveil (2.9%); IN.PACT (0.9%)
Effectiveness Results:
The rate of primary patency at 24 months was 64.9% in the SurVeil DCB group compared to 66.9% in the IN.PACT Admiral DCB group (The difference in rates between the groups was -1.9% with one-sided lower 97.5% CL of -12.1%).
At 60 months, the KM estimate of freedom from CD-TLR was 76.6% in the SurVeil DCB group and 75.7% in the IN.PACT Admiral DCB group (P=0.991).
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| Actual Number of Patients Enrolled |
A total of 1,005 subjects were enrolled in the trial, a total of 446 subjects were randomized and treated by 52 US sites and 13 OUS sites. Of the 446 randomized subjects, 290 (65.0%) subjects were randomized in the US and 156 (35.0%) were randomized OUS; 222 (49.8%) subjects were randomized to treatment with the SurVeil drug-coated balloon (DCB) and 224 (50.2%) subjects were randomized to treatment with the IN.PACT Admiral DCB.
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| Actual Number of Sites Enrolled |
71 investigational sites enrolled subjects in 10 countries worldwide
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| Patient Follow-up Rate |
A total of 321 of 343 eligible subjects (93.6%) completed their 48-month follow-up visit. Of them, 307 subjects (89.5%) completed their visit within window. As of 1 April 2024, a total of 216 of 231 eligible subjects (93.5%) completed their 60-month follow-up visit (87.0% follow-up compliance for SurVeil DCB and 89.4% for IN.PACT Admiral DCB). Of them, 204 subjects (88.3%) completed their visit within window. However, when both in- and out-of-window visits were considered, the rate of visit com
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