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Clinical Trials/DRKS00028124
DRKS00028124
Completed
Not Applicable

Prospective, multicenter, non-randomized, single-arm observational study to evaluate safety and effectiveness of iCover covered stent for the treatment of the aorto-iliac Occlusive Disease - ILICO

IVascular0 sites240 target enrollmentFebruary 15, 2022
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ConditionsAorto-Iliacal Artheropathy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aorto-Iliacal Artheropathy
Sponsor
IVascular
Enrollment
240
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 15, 2022
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
IVascular

Eligibility Criteria

Inclusion Criteria

  • •1\. \= 18 years of age
  • •2\. Rutherford clinical stage 2 to 5
  • •3\. Atheromatous aorto\-iliac lesions evidenced by duplex scan, CT angiography or arteriography.
  • •4\. De novo atheromatous lesion of the aortoiliac segment
  • •5\. Patient informed about the study and collection of the patient's informed consent agreement.

Exclusion Criteria

  • •1\. Protected adult patients, guardianship, curatorship, safeguard of justice
  • •2\. Woman with possibility of pregnancy
  • •3\. Patient with asymptomatic atheromatous lesions
  • •4\. Patient with inflow lesion in the infrarenal aorta
  • •5\. Patient treated with Covered endovascular reconstruction of aortic bifurcation (CERAB reconstruction)
  • •6\. Acute ischemia or acute thrombosis
  • •7\. Non\-atherosclerotic disease
  • •8\. History of coagulopathy
  • •9\. Severe comorbidities with life expectancy \<2 years
  • •10\. Contraindication to taking antiplatelet aggregation therapy (aspirin or clopidogrel). The patient must be able to take an antiplatelet aggregation for at least 3 months after the procedure

Outcomes

Primary Outcomes

Not specified

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