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Clinical Trials/KCT0005057
KCT0005057
Recruiting
未知

IntravasCular Imaging-Guided Versus AngiogRaphy-GUided Drug-Eluting Stent Implantation for Fermoropopliteal Artery Disease, A feasibility study

Asan Medical Center0 sites100 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Diseases of the circulatory system
Sponsor
Asan Medical Center
Enrollment
100
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional Study
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\.20 years of age\=85 years of age.
  • 2\.Intermittent claudication or tissue loss suitable for elective endovascular intervention (Rutherford category 2,3,4, or 5\)
  • 3\.Significant native superficial femoral or proximal popliteal artery lesions suitable for stent implantation(residual angiographic stenosis \=70% ). Restenotic lesions can be enrolled at least 12\-month after the index procedure uding plain balloon or drug\-coated balloon.
  • 4\.Total lesion length of 30 to 220 mm
  • 5\.Reference vessel diameter of 4 – 6 mm
  • 6\.The patient or fuardian agrees written conenst to the study protocol.

Exclusion Criteria

  • 1\.Existence of a stent in the target vessel
  • 2\.Previous use of atherectomy device in the target vessel
  • 3\.Use of drug\-coated balloon in the target vessel within 12\-month
  • 4\.Significant stenosis or occlusion (diameter stenosis \=70%) in all 3 infrapopliteal arteries
  • 5\.A known intolerance or contraindication to antiplatelet drugs (aspirin or clopidogrel)

Outcomes

Primary Outcomes

Not specified

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