UMIN ID: UMIN000008433
Registered date:13/07/2012
ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy. -Prospective multicenter registry-
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Peripheral artery disease |
| Date of first enrollment | 2012/10/01 |
| Target sample size | 1000 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | One-year restenosis rates |
|---|---|
| Secondary Outcome | 1) All-cause mortality 2) CAD 3) MI 4) Stroke 5) Freedom from TVR 6) Surgical conversion rates 7) MLower-limb Major amputation rates 8) Technical complications of EVT 9) in-stent thrombosis 10) Bleeding complications |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) life expectancy <1 yrs 2) unsuccessful angioplasty 3) residual inflow lesion 4) ALI 5) active bleeding 6) allergy for nitinol |
Related Information
| Primary Sponsor | ZEPHYR Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | ZEPHYR Study Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Osamu Iida |
| Address | 3-1-69 Inabaso, Amagasaki-shi, Hyogo Japan |
| Telephone | 06-6416-1221 |
| iida.osa@gmail.com | |
| Affiliation | Kansai Rosai Hospital Cardiovascular Center |
| scientific contact | |
| Name | 1) Osamu Iida, 2) Hiroyoshi Yokoi |
| Address | 1) 3-1-69 Inabaso, Amagasaki-shi, Hyogo, 2) 3-2-1 Asano Kokurakita-ku kitakyushu Japan |
| Telephone | 06-6416-1221 |
| iida.osa@gmail.com | |
| Affiliation | 1) Kansai Rosai Hospital 2) Kokura Memorial Hospital 1) Cardiovascular Center, 2) department of cardiology |