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A prospective observational multicenter cohort study in patients with SFA lesions who underwent stenting in Kanagawa.

A prospective observational multicenter cohort study in patients with SFA lesions who underwent stenting in Kanagawa. - KPTA1-Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000011551
Enrollment
200
Registered
2013-08-23
Start date
2014-01-01
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

peripheral arterial disease

Interventions

None listed

Sponsors

Kikuna Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient criteria Patients who meet all of the following criteria will be included in the study: 1. Chronic arteriosclerosis obliterans afflicting the SFA area* (Rutherford classification 2-6) *Except for patients with acute (within 1 week after onset)/subacute (2 weeks to 1 month after onset) lower limb ischemia 2. Age: 20 years or older at the time of consent 3. Gender: Male or female 4. Patients who can be monitored for at least 24 months after surgery Lesion criteria 1. Superficial femoral artery stenosis or occlusive lesions. 2. At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included. In addition, patients with bilateral lesions or aorta-iliac artery lesions may be included. 3. Occlusive lesions may be included.

Exclusion criteria

Exclusion criteria: Patient criteria Patients who meet any of the following criteria should be excluded from the study: 1.Patients with or at risk of hemorrhagic complications or patients with bleeding* tendency *Bleeding such as hemophilia, capillary fragility, intracranial hemorrhage, gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage may be aggravated. 2.Pregnant or potentially pregnant women 3. Patients who are not eligible for the study in the opinion of the attending physician. Lesion criteria Lesions that meet any of the following criteria should be excluded from the study: 1.Remnant inflow (aorta-iliac artery lesion) 2.Severe calcification (lesions not expected to be appropriately expanded) 3.No arterial runoff below the knee

Design outcomes

Primary

MeasureTime frame
Restenosis rate (1 year, 2 year)

Secondary

MeasureTime frame
TLR, MACLE (1 year, 2 year)

Countries

Japan

Contacts

Public ContactYasutaka Yamauchi

Kikuna Memorial Hospital Cardiology

qqfw76rd@bell.ocn.ne.jp045-402-7111

Outcome results

None listed

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