PAD: peripheral artery disease
Conditions
Interventions
None listed
Sponsors
IVORY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient has signed and dated the informed consent. 2) Patient has symptoms of atherosclerotic peripheral arterial disease classified as Rutherford Category1,,2, 3, 4 or 5. 3) Patient has a resting ABI less than 0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI greater than 1.2) must have a TBI less than 0.8. 4) Patient has a de novo or restenotic lesion with greater 50% stenosis documented angiographically in the target lesion. 5) Patient agrees to return for a clinical status assessment and duplex ultrasound post-procedure at 12 months.
Exclusion criteria
Exclusion criteria: 1) Patient is under 18 years of age. 2) Patient is pregnant or breast-feeding. 3) Patient has significant stenosis (> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure (success is measured as smaller than 30% residual stenosis). 4) Patient has undergone an unsuccessful arterial interventional treatment of the legs (i.e., the treatment resulted in greater than 30% residual stenosis of a treated lesion) within 30 days prior to the study procedure. 5) Patient has any planned surgical or interventional procedure within 30 days after the study procedure. 6) Patient has a medical condition or disorder that would limit life expectancy to less than 1 year. 7) Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, or nitinol that, in the opinion of the investigator, cannot be adequately premedicated. 8) Patient has untreated angiographically-evident thrombus in the target lesion. 9) Patient has a bypass graft with an anastomosis in the target vessel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Twelve-month restenosis rate (Definition of restenosis;50% or more stenosis found on angiography or CTA, less than 2.4 PSVR found on duplex ultrasound) Restenosis is basically evaluated by duplex 12 plus or minus months after endovascular procedure. | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactOsamu Iida
Japan Labour Health and Welfare Organization, Kansai Rosai Hospital Department of Cardiovascular Medicine
Outcome results
None listed