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Clinical Trials/NCT05296031
NCT05296031
Completed
N/A

Randomized Trial Comparing Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex in Critical Limb Ischemia and Treatment of Lesions in Femoral and Popliteal Arteries"

Skane University Hospital0 sites49 target enrollmentMarch 1, 2013
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ConditionsVascular Diseases

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vascular Diseases
Sponsor
Skane University Hospital
Enrollment
49
Primary Endpoint
Freedom from TLR (Target Lesion Revascularization)
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.

Registry
clinicaltrials.gov
Start Date
March 1, 2013
End Date
August 31, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Torbjorn Fransson

Principal Investigator, Consultant Vascular Surgeon

Skane University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Critical limb ischemia RC 4-6
  • •Lesions in superficial femoral artery and popliteal artery (p1 -p2)
  • •Target vessel 4-8mm
  • •At least I 1 vessel runoff to the foot
  • •Age \>18 years

Exclusion Criteria

  • •Patient disapproval
  • •Age \<18 years

Outcomes

Primary Outcomes

Freedom from TLR (Target Lesion Revascularization)

Time Frame: 24 months

Fraction of study subjects without need for retreatment at treatment location

Open (functioning and not stenosed) vascular reconstruction (Primary Patency)

Time Frame: 24 months

Functioning revascularization without adjunctive measures

Event Free Survival

Time Frame: 24 months

Alive without vascular events

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