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Eluvia OVER-THE-WIRE drug-eluting vascular stent system for the treatment of long segment femoral and popliteal artery stenosis or occlusive diseases: a prospective, non randomized, multicenter, real-world study

Eluvia OVER-THE-WIRE drug-eluting vascular stent system for the treatment of long segment femoral and popliteal artery stenosis or occlusive diseases: a prospective, non randomized, multicenter, real-world study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093932
Enrollment
Unknown
Registered
2024-12-13
Start date
2025-01-15
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

long segment femoral and popliteal artery stenosis or occlusive diseases

Interventions

Eluvia group (Eluvia drug-eluting vascular stent system):None

Sponsors

Beijing Anzhen Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Patients over 18 years old; • Lesion(s) length = 15cm (single lesion = 15cm, multiple segments with interval length no longer than 3cm can be seen as one lesion); • Rutherford category grade 2 or above; • Sign informed consent form; • Treatment of patients with long segment SFA and/or PPA stenosis or occlusive disease using Eluvia, reference vessel diameter 4.0-6.0 mm.

Exclusion criteria

Exclusion criteria: • Life expectation less than 1 year; • Use of IVL or other debulking devices in the target lesion during the index procedure; • Bare metal stent(s) and/or covered stent(s) implanted in the target lesion during the index procedure.

Design outcomes

Primary

MeasureTime frame
primary patency at 12 months;—

Secondary

MeasureTime frame
ABI change rate at 3 months;ABI change rate at 6 months;ABI change rate at 12 months;ABI change rate at 24 months;ABI change rate at 36 months;Changes of Rutherford category at 3 months;Changes of Rutherford category at 6 months;Changes of Rutherford category at 12 months;Changes of Rutherford category at 24 months;Changes of Rutherford category at 36 months;Primary patency rate at 6 months;Primary patency rate at 36 months;Freedom from Clinical driven target lesion revascularization (FFCD-TLR) at 3 months;Freedom from Clinical driven target lesion revascularization (FFCD-TLR) at 6 months;Freedom from Clinical driven target lesion revascularization (FFCD-TLR) at 12 months;Freedom from Clinical driven target lesion revascularization (FFCD-TLR) at 24 months;Freedom from Clinical driven target lesion revascularization (FFCD-TLR) at 36 months;Assisted primary patency rates at 6 months;Assisted primary patency rates at 12 months;Evaluation of changes in VascuQoL patient questionnaire compared to baseline;—

Countries

China

Contacts

Public ContactChen Zhong

Beijing Anzhen Hospital Affiliated to Capital Medical University

chenzhong8658@vip.sina.com+86 189 1166 2898

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026