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Real DES study -Zilver PTX vs Eluvia for femoropopliteal disease in multicenter prospective study-

Real DES study -Zilver PTX vs Eluvia for femoropopliteal disease in multicenter prospective study- - Real DES study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000036798
Enrollment
400
Registered
2019-05-20
Start date
2019-02-07
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

Obstructive arteriosclerosis of superficial femoral artery lesion.

Interventions

None listed

Sponsors

Hakodate Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 20 years old or older. 2) Atherosclerosis, with symptoms of peripheral artery disease (Rutherford Category 1 to 6). 3) Resting ABI is less than 0.9. Or, if the ABI is 0.9 or more, ischemia is evaluated in another test. 4) A stenosis evaluated by angiography or CT or MRI in the FPA area shows 50% or more or occlusion, or a stenosis or occlusion of PSVR> 2.4 in vascular echo (whether a new lesion or a restenotic lesion does not matter)

Exclusion criteria

Exclusion criteria: 1) Significant constriction (50% or more) in the ipsilateral proximal CFA or iliac artery area or aorta, or unsuccessful (30% or more residual stenosis) inflowing stenosis or occlusion before this procedure . However, if simultaneous treatment (EVT for iliac and femoral arteries) is planned, entry is possible. 2) Surgical bypass surgery and major amputation are planned within 30 days after EVT. 3) Cases with untreated angiographically evident thrombi in the target lesion 4) Cases with anastomotic lesions after bypass surgery

Design outcomes

Primary

MeasureTime frame
Of the first year primary patency/secondary patency

Countries

Japan

Contacts

Public ContactTsuyoshi Shibata

Hakodate Municipal Hospital Cardiovascular surgery

shibatatsuyoshi0827@yahoo.co.jp0138-43-2000

Outcome results

None listed

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