IntraVascular UltrasOund SuppoRted Endovascular Therapy in Superficial Femoral ArterY Disease Prospective multicenter registry

Not Applicable

Recruiting

• Conditions: PAD: peripheral artery disease

• Registration Number: JPRN-UMIN000020472
• Lead Sponsor: IVORY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified