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Usage of Contemporary Drug-Eluting Stent by Japanese Interventional Radiologists for Femoropopliteal In-Stent Restenosis lesions -Prospective multicenter study-

Usage of Contemporary Drug-Eluting Stent by Japanese Interventional Radiologists for Femoropopliteal In-Stent Restenosis lesions - COMBAT-ISR prospective multicenter study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036174
Enrollment
100
Registered
2019-03-12
Start date
2019-03-11
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Femoropopliteal In-Stent Restenosis

Interventions

1. Patients were treated with the ELUVIA drug eluting vascular stent (Boston Scientific, Marlborough, MA, USA, Indiana) The protocol specified planned treatment with a maximum of 3 ELUVIA drug eluting

Sponsors

Department of Radiology and Interventional neuroradiology,Ishinkai Yao General Hospital Department of Radiology and IVR center, Nara Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria were age >= 40 years, symptomatic PAD (Rutherford-Becker category 2 to 5), ISR >50% in the SFA and P1 segment of the popliteal artery, and a distal run off of at least 1 artery

Exclusion criteria

Exclusion criteria: Exclusion criteria were inability to give written informed consent; known allergy, hypersensitivity, or intolerance to radiologic contrast media, aspirin, clopidogrel or ticlopidine, and paclitaxel; and creatinine >2.5 mg/dl (except hemodialysis patients).

Design outcomes

Primary

MeasureTime frame
Primary patency at 12-month follow-up—

Secondary

MeasureTime frame
1)Technical success rate 2)Major adverse event within 30 days 3)Freedom from target lesion revascularization at 6,12 and 24 months—

Countries

Japan

Contacts

Public ContactTAKAYAMA KATSUTOSHI

Ishinkai Yao General Hospital Department of Radiology and Interventional neuroradiology

takayamaneuroivs@par.odn.ne.jp81-72-948-2500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026